A Phase 3 interventional study of HYQVIA in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Baxalta now part of Shire. Completed at 35 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Baxalta now part of Shire (part of Takeda) · Phase 3, Interventional, and Treatment
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Among 11 studies testing Immunoglobulin G in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — 2 open to participants now, 2 under way, 2 of them phase 3. Immunoglobulin G · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Among the 11 studies testing Immunoglobulin G in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, this one is the 3rd largest by enrollment, is the only one that started in 2016, is one of 6 in phase 3, and was the 9th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →2 of the 11 studies testing Immunoglobulin G in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating are open now, in 12 countries. Recruiting first, the newest first:
Grifols Therapeutics LLC · Sites in United States, Czechia, Poland and 1 more country
Ages 18+
Takeda · Sites in United States, Argentina, Czechia and 8 more countries
Ages 18+
By country, each count listing its studies:
Immunoglobulin G: first FDA approval 1944 (Baygam, Gamastan S/D), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 7 · Phase 4 1
First in 1990; this study’s year is marked. 1 started in 2016.
This study's enrollment of 85 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 50 across the 11 interventional studies. Of the 7 that completed or were terminated, 4 (57%) have results posted.
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7 of 11 have an industry lead sponsor. The 9 most frequent:
This study is registered under Baxalta now part of Shire, one of the names counted as Takeda. Under that name alone:
Baxalta now part of Shire is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Takeda has 7 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing Immunoglobulin G in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.
The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia.
All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so.
Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received HYQVIA/HyQvia (recombinant human hyaluronidase \[rHuPH20\] at a dose of 80 units per gram (U/g) immunoglobulin G \[IgG\], followed by subcutaneous \[SC\] immune globulin infusion \[IGI\] 10%) at the same monthly equivalent dose as the individual participant's IgG treatment in Study 161403, every 3 or 4 weeks in this Extension Study for 77.3 months or until relapse.
Biological: HYQVIA
Drug pages: Immunoglobulin G · Hyaluronoglucosaminidase
Participants received HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Also known as: 10%) with recombinant human hyaluronidase (rHuPH20), Immune Globulin Infusion 10% (Human) (IGI, IGI
Number of Participants With Any Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), Regardless of Causality
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Treatment emergent adverse events (TEAEs) were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With Causally Related Treatment-emergent SAEs and AEs
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Causality was used to determine whether there was a reasonable possibility that the IP was etiologically related to/associated with the AE.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With Adverse Reactions (ARs) or Suspected Adverse Reactions (SARs) Categorized as Serious and Non-serious
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Serious AR/SAR=any AR/SAR that is an untoward medical occurrence which at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect,is a medically important event,thromboembolic events,hemolytic anemia. Nonserious AR/SAR=AR/SAR that does not meet the criteria.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Percentage of Participants With Treatment-Emergent Adverse Events That May be a Result of Immune-Mediated Responses
Percentage of participants with TEAEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex-mediated reactions: local, complex-mediated reactions: systemic, thrombotic and embolic events were assessed. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. The percentage was rounded off to the nearest decimal.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Treatment-Emergent SAEs and AEs Associated With Infusions, Regardless of Causality
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AEs associated with an infusion are defined as AEs occurring after administration of IP (or any TEAE). Participants can have more than one TEAE associated with infusion.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Causally Related Treatment-Emergent SAEs and AEs Associated With Infusions
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AEs associated with an infusion are defined as AEs occurring after administration of IP (or any TEAE). Causality was used to determine whether there was a reasonable possibility that the IP was etiologically related to/associated with the AE.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of TEAEs Temporally Associated With Infusions
TEAEs that occurred during infusion or within 72 hours post-infusion were considered to be temporally associated with infusions. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Participants can have more than one TEAE temporally associated with infusion.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Serious and Non-Serious ARs or SARs Associated With Infusions
An AR/SAR=any AE that meets any of following criteria: AE considered by either investigator and/or sponsor to be possibly or probably related to IP administration, begins during infusion of IP or within 72 hours following end of IP infusion,or AE for which causality assessment is missing or indeterminate. ARs/SARs associated with an infusion=AEs considered by the investigator to be occurring after administration of IP. Serious AR/SAR=any AR/SAR that is an untoward medical occurrence which at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect,is a medically important event,thromboembolic events,hemolytic anemia. Nonserious AR/SAR=AR/SAR that does not meet the criteria. Participants can have more than one AR/SAR associated with infusion.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Infusions Associated With One or More Systemic TEAEs
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Infusions associated with one or more AEs are defined as follows: if an AE occurs after an infusion but prior to the next infusion that infusion is associated with that AE.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Infusions Associated With One or More Local TEAEs
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Infusions associated with one or more AEs are defined as follows: if an AE occurs after an infusion but prior to the next infusion that infusion is associated with that AE.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or TEAEs
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Infusion
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per Participant
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of TEAEs Categorized as Systemic and Local Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Infusion
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per Participant
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of IP-Related TEAEs Categorized as Systemic and Local, Expressed as Number of Events Per 1000 Participant-year
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Infusion
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per Participant
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of ARs or SARs Categorized as Local and Systemic, Expressed as Reactions Per 1000 Participant-year
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With a TEAE That Led to Discontinuation From Study
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. A moderate or severe AE could be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex-mediated reactions: local, complex-mediated reactions: systemic, thrombotic and embolic events. The severity of each AE was assessed by the investigator using clinical expertise based on the following description: moderate=AE produces limited impairment of function and may require therapeutic intervention and produces no sequela/sequelae; severe=AE results in a marked impairment of function and may lead to temporary inability to resume usual life pattern and produces sequela/sequelae, which require (prolonged) therapeutic intervention.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Rate of Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses, Expressed as Number of Events Per 100 Infusions
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. A moderate or severe AE could be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other concomitant medications. The severity of each AE was assessed by the investigator using clinical expertise. Data for number of events per 100 infusions was assessed at the group level calculated by dividing number of events by total number of infusions and multiplying that by 100.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants That Experienced Treatment-Emergent Local Infusion Site Reactions
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. All local infusion site treatment-emergent AEs were reported as adverse reactions.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With Treatment-Emergent Local Tolerability Events During Ramp-up
Participants with local tolerability events were those for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs. These events were assessed during the initial ramp-up for each participant i.e., during the first 8 weeks of open-label extension study 161505 \[NCT02955355\] among participants originally randomized to placebo (as being in the placebo arm, they had no ramp-up during the 161403 \[NCT02549170\] study) versus during the 8-week ramp-up for participants originally randomized to active HYQVIA in double-blind 161403 study. Thus, the data for this outcome measure are presented per the bifurcation of participants in the study 161403.
Time frame: During the ramp-up (8 weeks)
Number of Participants With Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate Per Site, and Infusion Volume Per Site
Local infusion reactions were defined as local (administration site-related) adverse events. Median infusion rate per site was derived as the median value across all participants, per participant's average infusion rate, by site: actual volume infused / duration in hours of infusion / number of sites. Median infusion volume per site was derived as the median value across all participants, per participant's average actual volume infused, by site: actual volume infused / number of sites. Number of participants with local infusion reactions as a function of each of the categories are presented below.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants Whose Anti-Hyaluronidase Binding Antibody Titers Rose by ≥4-fold From Baseline
Number of participants whose anti-hyaluronidase antibody titers rose by ≥4 fold from the baseline value at any point during the study was assessed.
Time frame: Baseline, up to 6.6 years
Number of Participants With Binding Antibodies to rHuPH20
Binding antibodies were defined as anti-rHuPH20 titer ≥1:160.
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With Neutralizing Antibodies Binding to rHuPH20
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants With a Decline of Anti-rHuPH20 Binding Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or to <1:160 Antibody Titer Level at the Study Completion or Early Discontinuation
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers With Neutralizing Antibodies
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers Showing Cross Reactivity With Hyaluronidase (Hyal)-1,2 and 4
Time frame: From the first dose of study drug up to end of study (up to 6.6 years)
Participants took part in the study at 39 investigative sites worldwide from 14 November 2016 to 04 July 2023.
| Milestone | HYQVIA/HyQvia |
|---|---|
| Started | 85 |
| Completed | 0 |
| Not completed | 85 |
| Withdrew: Adverse event | 4 |
| Withdrew: Death | 1 |
| Withdrew: Physician decision | 21 |
| Withdrew: Site terminated by sponsor | 35 |
| Withdrew: Withdrawal by subject | 19 |
| Withdrew: Reason not specified | 5 |
An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Treatment emergent adverse events (TEAEs) were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
| Participants | HYQVIA/HyQvia |
|---|---|
| Any TEAE | 76 |
| Any Serious TEAE | 20 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Causality was used to determine whether there was a reasonable possibility that the IP was etiologically related to/associated with the AE.
| Participants | HYQVIA/HyQvia |
|---|---|
| Any IP-Related TEAE | 51 |
| Any IP-Related Serious TEAE | 3 |
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Serious AR/SAR=any AR/SAR that is an untoward medical occurrence which at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect,is a medically important event,thromboembolic events,hemolytic anemia. Nonserious AR/SAR=AR/SAR that does not meet the criteria.
| Participants | HYQVIA/HyQvia |
|---|---|
| Any Serious AR/SAR | 7 |
| Any Non-serious AR/SAR | 57 |
Percentage of participants with TEAEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex-mediated reactions: local, complex-mediated reactions: systemic, thrombotic and embolic events were assessed. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. The percentage was rounded off to the nearest decimal.
| percentage of participants | HYQVIA/HyQvia |
|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events That May be a Result of Immune-Mediated Responses | 7.1 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AEs associated with an infusion are defined as AEs occurring after administration of IP (or any TEAE). Participants can have more than one TEAE associated with infusion.
| events in participants | HYQVIA/HyQvia |
|---|---|
| Serious TEAEs | 30 |
| TEAEs | 1406 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, was life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AEs associated with an infusion are defined as AEs occurring after administration of IP (or any TEAE). Causality was used to determine whether there was a reasonable possibility that the IP was etiologically related to/associated with the AE.
| events in participants | HYQVIA/HyQvia |
|---|---|
| IP-Related Serious TEAEs | 3 |
| IP-Related TEAEs | 798 |
TEAEs that occurred during infusion or within 72 hours post-infusion were considered to be temporally associated with infusions. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Participants can have more than one TEAE temporally associated with infusion.
| events in participants | HYQVIA/HyQvia |
|---|---|
| Number of TEAEs Temporally Associated With Infusions | 857 |
An AR/SAR=any AE that meets any of following criteria: AE considered by either investigator and/or sponsor to be possibly or probably related to IP administration, begins during infusion of IP or within 72 hours following end of IP infusion,or AE for which causality assessment is missing or indeterminate. ARs/SARs associated with an infusion=AEs considered by the investigator to be occurring after administration of IP. Serious AR/SAR=any AR/SAR that is an untoward medical occurrence which at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect,is a medically important event,thromboembolic events,hemolytic anemia. Nonserious AR/SAR=AR/SAR that does not meet the criteria. Participants can have more than one AR/SAR associated with infusion.
| events in participants | HYQVIA/HyQvia |
|---|---|
| Serious ARs/SARs | 8 |
| Non-Serious ARs/SARs | 913 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Infusions associated with one or more AEs are defined as follows: if an AE occurs after an infusion but prior to the next infusion that infusion is associated with that AE.
| infusions | HYQVIA/HyQvia |
|---|---|
| Number of Infusions Associated With One or More Systemic TEAEs | 50 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Infusions associated with one or more AEs are defined as follows: if an AE occurs after an infusion but prior to the next infusion that infusion is associated with that AE.
| infusions | HYQVIA/HyQvia |
|---|---|
| Number of Infusions Associated With One or More Local TEAEs | 17 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
| infusions | HYQVIA/HyQvia |
|---|---|
| Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or TEAEs | 3 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
| AEs/infusion | HYQVIA/HyQvia |
|---|---|
| Systemic TEAEs | 0.25 |
| Local TEAEs | 0.15 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
| AEs/participant | HYQVIA/HyQvia |
|---|---|
| Systemic TEAEs | 10.38 |
| Local TEAEs | 6.16 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
| AEs/1000 participant-year | HYQVIA/HyQvia |
|---|---|
| Systemic TEAEs | 4000.23 |
| Local TEAEs | 2376.55 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
| AEs/infusion | HYQVIA/HyQvia |
|---|---|
| Systemic IP-Related TEAEs | 0.08 |
| Local IP-Related TEAEs | 0.15 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
| AEs/participant | HYQVIA/HyQvia |
|---|---|
| Systemic IP-Related TEAEs | 3.38 |
| Local IP-Related TEAEs | 6.01 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. Systemic TEAEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". An adverse event that was "possibly related" or "probably related" to IP, or for which the relationship was unknown or missing, was considered as a "related AE". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
| AEs/1000 participant-year | HYQVIA/HyQvia |
|---|---|
| Systemic IP-Related TEAEs | 1301.66 |
| Local IP-Related TEAEs | 2317.59 |
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per infusion was assessed at the group level calculated by dividing number of events by total number of infusions administered to participants in the Safety Analysis Set.
| reactions/infusion | HYQVIA/HyQvia |
|---|---|
| Systemic ARs/SARs | 0.11 |
| Local ARs/SARs | 0.15 |
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Data for number of events per participant was assessed at the group level calculated by dividing number of events by total number of participants in the Safety Analysis Set.
| reactions/participant | HYQVIA/HyQvia |
|---|---|
| Systemic ARs/SARs | 4.58 |
| Local ARs/SARs | 6.16 |
An AR plus SAR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 hours following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Systemic AEs were defined as AEs that were not included in the MedDRA Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site". Local AEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infection site". Events per participant-years was calculated as follows: 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the Safety Analysis Set, divided by 365.25).
| reactions/1000 participant-year | HYQVIA/HyQvia |
|---|---|
| Systemic ARs/SARs | 1764.27 |
| Local ARs/SARs | 2376.55 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study.
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants With a TEAE That Led to Discontinuation From Study | 4 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. A moderate or severe AE could be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex-mediated reactions: local, complex-mediated reactions: systemic, thrombotic and embolic events. The severity of each AE was assessed by the investigator using clinical expertise based on the following description: moderate=AE produces limited impairment of function and may require therapeutic intervention and produces no sequela/sequelae; severe=AE results in a marked impairment of function and may lead to temporary inability to resume usual life pattern and produces sequela/sequelae, which require (prolonged) therapeutic intervention.
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants With Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses | 3 |
An AE was defined as any untoward medical occurrence in a participant administered an IP that did not necessarily have a causal relationship with the treatment. TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. A moderate or severe AE could be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other concomitant medications. The severity of each AE was assessed by the investigator using clinical expertise. Data for number of events per 100 infusions was assessed at the group level calculated by dividing number of events by total number of infusions and multiplying that by 100.
| AEs/100 infusions | HYQVIA/HyQvia |
|---|---|
| Rate of Moderate or Severe TEAEs That May be a Result of Immune-Mediated Responses, Expressed as Number of Events Per 100 Infusions | 0.0860 |
TEAEs were defined as adverse events that occurred during or after administration of the first dose of IP in this Extension Study. AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. All local infusion site treatment-emergent AEs were reported as adverse reactions.
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants That Experienced Treatment-Emergent Local Infusion Site Reactions | 30 |
Participants with local tolerability events were those for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs. These events were assessed during the initial ramp-up for each participant i.e., during the first 8 weeks of open-label extension study 161505 \[NCT02955355\] among participants originally randomized to placebo (as being in the placebo arm, they had no ramp-up during the 161403 \[NCT02549170\] study) versus during the 8-week ramp-up for participants originally randomized to active HYQVIA in double-blind 161403 study. Thus, the data for this outcome measure are presented per the bifurcation of participants in the study 161403.
| Participants | Placebo Then HYQVIA/HyQvia | HYQVIA/HyQvia Then HYQVIA/HyQvia |
|---|---|---|
| Number of Participants With Treatment-Emergent Local Tolerability Events During Ramp-up | 6 | 13 |
Local infusion reactions were defined as local (administration site-related) adverse events. Median infusion rate per site was derived as the median value across all participants, per participant's average infusion rate, by site: actual volume infused / duration in hours of infusion / number of sites. Median infusion volume per site was derived as the median value across all participants, per participant's average actual volume infused, by site: actual volume infused / number of sites. Number of participants with local infusion reactions as a function of each of the categories are presented below.
| Participants | HYQVIA/HyQvia |
|---|---|
| 3 Week Dosing Interval | 8 |
| 4 Week Dosing Interval | 22 |
| < Median Infusion Rate per Site | 15 |
| ≥ Median Infusion Rate per Site | 15 |
| < Median Infusion Volume per Site | 15 |
| ≥ Median Infusion Volume per Site | 15 |
Number of participants whose anti-hyaluronidase antibody titers rose by ≥4 fold from the baseline value at any point during the study was assessed.
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants Whose Anti-Hyaluronidase Binding Antibody Titers Rose by ≥4-fold From Baseline | 16 |
Binding antibodies were defined as anti-rHuPH20 titer ≥1:160.
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants With Binding Antibodies to rHuPH20 | 14 |
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants With Neutralizing Antibodies Binding to rHuPH20 | 2 |
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants With a Decline of Anti-rHuPH20 Binding Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or to <1:160 Antibody Titer Level at the Study Completion or Early Discontinuation | 12 |
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers With Neutralizing Antibodies | 2 |
| Participants | HYQVIA/HyQvia |
|---|---|
| Number of Participants Who Had >1:10,000 Anti-rHuPH20 Binding Antibody Titers Showing Cross Reactivity With Hyaluronidase (Hyal)-1,2 and 4 | 0 |
Collected over From the first dose of study drug up to end of study (up to 6.6 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HYQVIA/HyQvia | 1/85 (1.2%) | 20/85 (23.5%) | 63/85 (74.1%) |
| Event | HYQVIA/HyQvia |
|---|---|
| Inguinal herniaGastrointestinal disorders | 2/85 |
| Abdominal painGastrointestinal disorders | 1/85 |
| AppendicitisInfections and infestations | 1/85 |
| COVID-19Infections and infestations | 1/85 |
| Cardiac failureCardiac disorders | 1/85 |
| CholangiocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/85 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 1/85 |
| Conus medullaris syndromeNervous system disorders | 1/85 |
| DepressionPsychiatric disorders | 1/85 |
| DiarrhoeaGastrointestinal disorders | 1/85 |
| Event | HYQVIA/HyQvia |
|---|---|
| HeadacheNervous system disorders | 23/85 |
| COVID-19Infections and infestations | 18/85 |
| PyrexiaGeneral disorders | 17/85 |
| Infusion site erythemaGeneral disorders | 13/85 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/85 |
| FatigueGeneral disorders | 12/85 |
| DiarrhoeaGastrointestinal disorders | 11/85 |
| NauseaGastrointestinal disorders | 11/85 |
| HypertensionVascular disorders | 8/85 |
| InfluenzaInfections and infestations | 8/85 |
Safety Analysis Set included all participants who were enrolled in this Extension Study and who received at least one dose of study medication.
| Age, Continuous(years) | HYQVIA/HyQvia |
|---|---|
| Mean | 54.3 ± 13.11 |
| Sex: Female, Male(Participants) | HYQVIA/HyQvia |
|---|---|
| Female | 39 |
| Male | 46 |
| Ethnicity (NIH/OMB)(Participants) | HYQVIA/HyQvia |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 67 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | HYQVIA/HyQvia |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 81 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Height(centimeters (cm)) | HYQVIA/HyQvia |
|---|---|
| Mean | 171.5 ± 10.98 |
| Weight(kilograms (kg)) | HYQVIA/HyQvia |
|---|---|
| Mean | 80.89 ± 18.856 |
| Body Mass Index (BMI)(kilograms per meter square (kg/m^2)) | HYQVIA/HyQvia |
|---|---|
| Mean | 27.42 ± 5.587 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Nov 2016 to primary completion in Jul 2023, 79 months.
Results were first posted in Aug 2024, 1 year 1 month after primary completion.
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Studies of the drugs tested here: Immunoglobulin G · Hyaluronoglucosaminidase
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →