A Phase 3 interventional study of CINRYZE 500 U and CINRYZE 1000 U in Hereditary Angioedema (HAE), sponsored by Shire. Completed at 10 sites in Japan. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Shire · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
164 studies on the registry are indexed under Angioedema; 19 are open to participants now.
This study's enrollment of 8 is below the median of 44 across 111 interventional studies indexed under Angioedema.
Browse Angioedema studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Meet the following minimum body weight criteria:
If a female of reproductive age, be postmenopausal (≥12 months following cessation of menstruation), surgically sterile, or following an acceptable method of birth control (and agree to continue its use through 1 month after the last dose of study drug):
OR If a child or minor (\<20 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (ie, permission) for the child to participate in the study before any study-specific procedures are performed. Assent will be obtained from children ≥14 years of age.
Exclusion Criteria:
500 U of CINRYZE will be administered by IV infusion twice weekly for 12 weeks
Drug: CINRYZE 500 U
1000 U of CINRYZE will be administered by IV infusion twice weekly for 12 weeks.
Drug: CINRYZE 1000 U
IV infusion administered twice weekly
IV infusion administered twice weekly
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with the treatment. TEAEs were defined as all AEs that started during the treatment period and up to 7 days after the last dose of investigational product, or AEs that were seen at baseline but worsened in frequency and/or severity during the treatment period and up to 7 days after the last dose of investigational product.
Time frame: From start of study drug administration up to Week 12
Number of Participants With Clinically Significant Abnormalities in Physical Examination Reported as Adverse Events (AEs)
Physical examinations included measurement of body weight and height. Clinically significant abnormalities related to physical examination as determined by investigator were recorded and reported as AE.
Time frame: From start of study drug administration up to Week 12
Number of Participants With Potentially Clinically Important (PCI) Vital Signs Reported as Adverse Events (AEs)
Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate. Investigator used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified as: SBP (less than \[\<\] 90 millimeter of mercury \[mmHg\]; greater than or equal to \[\>=\] 140 mmHg), DBP (\< 60 mmHg; \>=90 mmHg) and pulse (less than or equal to \[\<=\] 50 beats per minute \[bpm\]; \>= 100 bpm. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.
Time frame: Baseline up to Week 12
Number of Participants With Potentially Clinically Important (PCI) Clinical Laboratory Assessments Reported as Adverse Events (AEs)
Number of participants with potentially clinically important (PCI) clinical laboratory assessments reported as adverse events were reported.
Time frame: Baseline up to Week 12
Concentration of C1 Esterase Inhibitor (C1 INH) Antigen (Protein Volume) at Week 1
C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.
Time frame: Week 1: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 hours (h) post-dose
Concentration of C1 Esterase Inhibitor (C1 INH) Antigen (Protein Volume) at Week 12
C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.
Time frame: Week 12: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose
Concentration of Plasma Complement C4 at Week 1
Concentration of plasma complement C4 was reported.
Time frame: Week 1: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose
Concentration of Plasma Complement C4 at Week 12
Concentration of plasma complement C4 was reported.
Time frame: Week 12: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose
Concentration of Plasma Complement C1q at Week 1
Concentration of plasma complement C1q was reported.
Time frame: Baseline (Week 1)
Normalized Number of Angioedema Attacks (NNA) Per Month
Angioedema attack was defined as any participant-reported (or caregiver-reported) indication of swelling or pain at any location following a report of no swelling or pain on the previous day (that is, there must have been a full symptom-free calendar day preceding the onset of symptoms for an attack to be considered a new attack). NNA was calculated as the overall number of angioedema attacks recorded during the period divided by the number of days in the period and multiplied by 30.4.Number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency as compared to the historical data where, NNA was the number of angioedema attacks during 3 months prior to study drug administration. Historical data was obtained from medical or angioedema history electronic case report forms (eCRF).
Time frame: Baseline up to Week 12
Number of Participants With Angioedema Attacks in Different Anatomic Locations
Anatomic locations where there was a presence of pain or swelling of any level of severity; mild, moderate or severe at any day during the attack were reported. Mild: the attack symptoms were noticeable but were easily tolerated by the participant and did not interfere with the participant's daily activities. Moderate: the attack symptoms interfered with the participant's ability to attend work/school or participate in family life and social/recreational activities and severe: the attack symptoms significantly limited the participant's ability to attend work/school or participate in family life and social/recreational activities. Number of participants with angioedema attacks in different anatomic locations in treatment period was compared to NNA for historical data. Historical data was based on the typical location of angioedema attacks in the 3 months prior to study drug administration. Here, H refers to historical and T refers to treatment.
Time frame: Baseline up to Week 12
Average Severity (Intensity) of Angioedema Attacks
All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the participant to any swelling location on any day during the attack. The average severity was derived by dividing the cumulative severity score by the total number of attacks. Average severity was set to 0 if there was no attack in a period. Average severity of angioedema attacks in treatment period compared to the NNA of angioedema attacks for historical data was reported. Historical data was based on the typical severity of angioedema attacks in the 3 months prior to study drug administration. Historical data was obtained from medical or angioedema history electronic case report forms (eCRF).
Time frame: Baseline up to Week 12
Average Duration of Angioedema Attacks
Average duration of attacks was calculated by dividing the cumulative duration of attacks by the total number of attacks during the treatment period. Historical data was based on the typical severity of angioedema attacks in the 3 months prior to study drug administration. Average duration of angioedema attacks in treatment period was compared to the NNA for historical data. Historical data was obtained from medical or angioedema history eCRF.
Time frame: Baseline up to Week 12
Normalized Number of Angioedema Attacks (NNA) Per Month Treated With Rescue Medication
The normalized number of angioedema attacks was calculated as the overall number of angioedema attacks recorded during the period divided by the number of days in the period and multiplied by 30.4. NNA treated with rescue medications were reported for CINRYZE, non-CINRYZE C1-INH or not treated with C1-INH (including attacks treated with any medications other than C1-INH or untreated attacks). CINRYZE was only considered as a rescue medication when treated for breakthrough attack treatment. For historical data, only medications taken prior to the start of drug study drug administration and had an indication of "hereditary angioedema (HAE) management - acute treatment" selected on the prior and concomitant medications and therapy were considered as rescue medications. Historical data was obtained from medical or angioedema history eCRF.
Time frame: Baseline up to Week 12
Number of Participants Achieving Clinical Responder Rate Relative to Historical Data
Number of participants achieving at least 50 percent (%), 70% or 90% reduction in NNA relative to NNA for historical data was reported.
Time frame: Baseline up to Week 12
Change From Baseline in Angioedema Quality of Life (AE-QoL) in Treatment Period
Angioedema quality of life (AE-QoL) questionnaire was a self-administered validated angioedema disease-specific quality of life instrument. It consisted of 17 specific questions that were associated with work, physical activity, free time, social relations, and diet. Each of the 17 items had a 5-point response scale ranging from 1 (Never) to 5 (Very Often). The questionnaire was scored according to the developers' guidelines to produce a total score and 4 domain scores (functioning, fatigue/mood, fear/shame, nutrition). Raw domain scores (mean of the item scores within each scale) and the raw total score (mean of all item scores) were rescaled using linear transformations into final percentage scores ranging 0 to 100, based on the maximum possible score, where the higher the score the greater the QoL impairment.
Time frame: Baseline, Week 12
Number of Participants With Breakthrough Angioedema Attacks
A breakthrough attack was defined as an angioedema attack that occurs during long-term prevention therapy with CINRYZE (that is, between first study drug and last study drug dose). Number of participants with 1, 2, 3 or more angioedema attacks and who achieved initial improvement and complete resolution were also reported. Breakthrough angioedema attacks assessed by CINRYZE treatment, non-CINRYZE C1 INH treatment and untreated with C1-INH were reported. Here BAA refers to breakthrough angioedema attacks.
Time frame: Baseline up to Week 12
Time From Attack Onset to Initial Improvement and Complete Resolution
Time to initial improvement (TII) was calculated from the time of study drug administration to initial symptom improvement. Time to complete resolution was defined as the time from the onset of attack to complete resolution of all symptoms. Time to initial improvement and time to complete resolution as assessed by CINRYZE, non-CINRYZE and untreated were reported.
Time frame: Baseline up to Week 12
Time From Onset of Attack to Time Treated by CINRYZE
The median time from onset of attack to time treated with CINRYZE was reported.
Time frame: Baseline up to Week 12
Time From Treatment With CINRYZE to Initial Improvement
Time to initial improvement was calculated from the time of study drug administration to initial symptom improvement. Median time from treatment with CINRYZE to initial improvement was reported.
Time frame: Baseline up to Week 12
The study was conducted in 9 study centers in Japan between 13 Sep 2016 (First participant first visit) and 23 June 2017 (Last participant last visit).
| Milestone | CINRYZE 500 U | CINRYZE 1000 U |
|---|---|---|
| Started | 0 | 8 |
| Completed | 0 | 8 |
| Not completed | 0 | 0 |
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with the treatment. TEAEs were defined as all AEs that started during the treatment period and up to 7 days after the last dose of investigational product, or AEs that were seen at baseline but worsened in frequency and/or severity during the treatment period and up to 7 days after the last dose of investigational product.
| Participants | CINRYZE 1000 U |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 7 |
Physical examinations included measurement of body weight and height. Clinically significant abnormalities related to physical examination as determined by investigator were recorded and reported as AE.
| Participants | CINRYZE 1000 U |
|---|---|
| Number of Participants With Clinically Significant Abnormalities in Physical Examination Reported as Adverse Events (AEs) | 0 |
Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate. Investigator used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified as: SBP (less than \[\<\] 90 millimeter of mercury \[mmHg\]; greater than or equal to \[\>=\] 140 mmHg), DBP (\< 60 mmHg; \>=90 mmHg) and pulse (less than or equal to \[\<=\] 50 beats per minute \[bpm\]; \>= 100 bpm. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.
| Participants | CINRYZE 1000 U |
|---|---|
| Number of Participants With Potentially Clinically Important (PCI) Vital Signs Reported as Adverse Events (AEs) | 0 |
Number of participants with potentially clinically important (PCI) clinical laboratory assessments reported as adverse events were reported.
| Participants | CINRYZE 1000 U |
|---|---|
| Number of Participants With Potentially Clinically Important (PCI) Clinical Laboratory Assessments Reported as Adverse Events (AEs) | 0 |
C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.
| Gram per liter (g/L) | CINRYZE 1000U |
|---|---|
| Pre-dose | 0.0581 ± 0.04877 |
| 0.5 h post-dose | 0.1463 ± 0.04210 |
| 1 h post-dose | 0.1426 ± 0.05795 |
| 2 h post-dose | 0.1436 ± 0.04524 |
| 6 h post-dose | 0.1413 ± 0.04376 |
| 24 h post-dose | 0.1147 ± 0.03825 |
| 48 h post-dose | 0.0978 ± 0.04204 |
| 72 h post-dose | 0.0881 ± 0.04133 |
| 96 h post-dose | 0.0680 ± NA |
C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.
| gram per liter (g/L) | CINRYZE 1000 U |
|---|---|
| Pre-dose | 0.0775 ± 0.04904 |
| 0.5 h post-dose | 0.1660 ± 0.04159 |
| 1 h post-dose | 0.1468 ± 0.03232 |
| 2 h post-dose | 0.1634 ± 0.04500 |
| 6 h post-dose | 0.1573 ± 0.03978 |
| 24 h post-dose | 0.1244 ± 0.04675 |
| 48 h post-dose | 0.1003 ± 0.05030 |
| 72 h post-dose | 0.0836 ± 0.05169 |
| 96 h post-dose | 0.0661 ± 0.05163 |
Concentration of plasma complement C4 was reported.
| Milligram per liter (mg/L) | CINRYZE 1000 U |
|---|---|
| Pre-dose | 42.8 ± 20.42 |
| 0.5 h post-dose | 37.5 ± 17.55 |
| 1 h post-dose | 32.7 ± 18.17 |
| 2 h post-dose | 43.3 ± 19.48 |
| 6 h post-dose | 69.0 ± 29.70 |
| 24 h post-dose | 89.0 ± 33.80 |
| 48 h post-dose | 82.5 ± 36.00 |
| 72 h post-dose | 80.5 ± 41.34 |
| 96 h post-dose | 67.0 ± NA |
Concentration of plasma complement C4 was reported.
| mg/L | CINRYZE 1000 U |
|---|---|
| Pre-dose | 77.9 ± 37.79 |
| 0.5 h post-dose | 65.0 ± 37.92 |
| 1 h post-dose | 41.4 ± 13.79 |
| 2 h post-dose | 67.5 ± 40.19 |
| 6 h post-dose | 91.1 ± 49.98 |
| 24 h post-dose | 104 ± 53.35 |
| 48 h post-dose | 99.3 ± 50.65 |
| 72 h post-dose | 77.9 ± 47.39 |
| 96 h post-dose | 63.2 ± 37.06 |
Concentration of plasma complement C1q was reported.
| International units per milliliter | CINRYZE 1000 U |
|---|---|
| Concentration of Plasma Complement C1q at Week 1 | 78.50 ± 36.598 |
Angioedema attack was defined as any participant-reported (or caregiver-reported) indication of swelling or pain at any location following a report of no swelling or pain on the previous day (that is, there must have been a full symptom-free calendar day preceding the onset of symptoms for an attack to be considered a new attack). NNA was calculated as the overall number of angioedema attacks recorded during the period divided by the number of days in the period and multiplied by 30.4.Number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency as compared to the historical data where, NNA was the number of angioedema attacks during 3 months prior to study drug administration. Historical data was obtained from medical or angioedema history electronic case report forms (eCRF).
| Angioedema attacks per month | CINRYZE 1000 U |
|---|---|
| Historical | 3.375 ± 2.5225 |
| CINRYZE Treatment | 1.826 ± 1.5031 |
Anatomic locations where there was a presence of pain or swelling of any level of severity; mild, moderate or severe at any day during the attack were reported. Mild: the attack symptoms were noticeable but were easily tolerated by the participant and did not interfere with the participant's daily activities. Moderate: the attack symptoms interfered with the participant's ability to attend work/school or participate in family life and social/recreational activities and severe: the attack symptoms significantly limited the participant's ability to attend work/school or participate in family life and social/recreational activities. Number of participants with angioedema attacks in different anatomic locations in treatment period was compared to NNA for historical data. Historical data was based on the typical location of angioedema attacks in the 3 months prior to study drug administration. Here, H refers to historical and T refers to treatment.
| Participants | CINRYZE 1000 U |
|---|---|
| Abdominal/Gastrointestinal: H | 7 |
| Abdominal/Gastrointestinal: T | 3 |
| Cutaneous - Facial: H | 3 |
| Cutaneous - Facial: T | 2 |
| Cutaneous - Extremity or Peripheral: H | 6 |
| Cutaneous - Extremity or Peripheral: T | 6 |
| Genital/Urinary (Includes scrotum or vulva): H | 2 |
| Genital/Urinary (Includes scrotum or vulva): T | 4 |
| Upper Airway (includes laryngeal or pharyngeal): H | 2 |
| Upper Airway (includes laryngeal or pharyngeal):T | 1 |
All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the participant to any swelling location on any day during the attack. The average severity was derived by dividing the cumulative severity score by the total number of attacks. Average severity was set to 0 if there was no attack in a period. Average severity of angioedema attacks in treatment period compared to the NNA of angioedema attacks for historical data was reported. Historical data was based on the typical severity of angioedema attacks in the 3 months prior to study drug administration. Historical data was obtained from medical or angioedema history electronic case report forms (eCRF).
| Units on a scale | CINRYZE 1000 U |
|---|---|
| Historical | 1.875 ± 0.8345 |
| CINRYZE Treatment | 0.970 ± 0.6441 |
Average duration of attacks was calculated by dividing the cumulative duration of attacks by the total number of attacks during the treatment period. Historical data was based on the typical severity of angioedema attacks in the 3 months prior to study drug administration. Average duration of angioedema attacks in treatment period was compared to the NNA for historical data. Historical data was obtained from medical or angioedema history eCRF.
| Days | CINRYZE 1000 U |
|---|---|
| Historical | 2.250 ± 1.0351 |
| CINRYZE Treatment | 1.941 ± 2.0630 |
The normalized number of angioedema attacks was calculated as the overall number of angioedema attacks recorded during the period divided by the number of days in the period and multiplied by 30.4. NNA treated with rescue medications were reported for CINRYZE, non-CINRYZE C1-INH or not treated with C1-INH (including attacks treated with any medications other than C1-INH or untreated attacks). CINRYZE was only considered as a rescue medication when treated for breakthrough attack treatment. For historical data, only medications taken prior to the start of drug study drug administration and had an indication of "hereditary angioedema (HAE) management - acute treatment" selected on the prior and concomitant medications and therapy were considered as rescue medications. Historical data was obtained from medical or angioedema history eCRF.
| Angioedema attacks per month | CINRYZE 1000 U |
|---|---|
| Historical Data | 1.750 ± 2.2660 |
| CINRYZE Treatment | 0.477 ± 0.8411 |
Number of participants achieving at least 50 percent (%), 70% or 90% reduction in NNA relative to NNA for historical data was reported.
| Participants | CINRYZE 1000 U |
|---|---|
| Achieving >= 50% reduction in NNA | 4 |
| Achieving >= 70% reduction in NNA | 3 |
| Achieving >= 90% reduction in NNA | 2 |
Angioedema quality of life (AE-QoL) questionnaire was a self-administered validated angioedema disease-specific quality of life instrument. It consisted of 17 specific questions that were associated with work, physical activity, free time, social relations, and diet. Each of the 17 items had a 5-point response scale ranging from 1 (Never) to 5 (Very Often). The questionnaire was scored according to the developers' guidelines to produce a total score and 4 domain scores (functioning, fatigue/mood, fear/shame, nutrition). Raw domain scores (mean of the item scores within each scale) and the raw total score (mean of all item scores) were rescaled using linear transformations into final percentage scores ranging 0 to 100, based on the maximum possible score, where the higher the score the greater the QoL impairment.
| Score on a scale | CINRYZE 1000 U |
|---|---|
| Total Score (Baseline) | 28.3 ± 12.79 |
| Total Score (Change from baseline) | -9.0 ± 16.72 |
| Functioning (Baseline) | 16.4 ± 11.54 |
| Functioning (Change from baseline) | -2.3 ± 22.39 |
| Fatigue/Mood (Baseline) | 18.8 ± 19.59 |
| Fatigue/Mood (Change from baseline) | -9.4 ± 14.00 |
| Fears/Shame (Baseline) | 49.5 ± 21.76 |
| Fears/Shame (Change from baseline) | -14.1 ± 21.12 |
| Nutrition (Baseline) | 12.5 ± 16.37 |
| Nutrition (Change from baseline) | -6.3 ± 24.09 |
A breakthrough attack was defined as an angioedema attack that occurs during long-term prevention therapy with CINRYZE (that is, between first study drug and last study drug dose). Number of participants with 1, 2, 3 or more angioedema attacks and who achieved initial improvement and complete resolution were also reported. Breakthrough angioedema attacks assessed by CINRYZE treatment, non-CINRYZE C1 INH treatment and untreated with C1-INH were reported. Here BAA refers to breakthrough angioedema attacks.
| Participants | CINRYZE 1000 U |
|---|---|
| Treated (CINRYZE) | 2 |
| Treated (NON-CINRYZE C1 INH) | 1 |
| Untreated | 6 |
| Treated (CINRYZE): One BAA | 1 |
| Treated (CINRYZE): Two BAA | 0 |
| Treated (CINRYZE): Three BAA | 1 |
| Treated (NON-CINRYZE C1 INH): One BAA | 0 |
| Treated (NON-CINRYZE C1 INH): Two BAA | 0 |
| Treated (NON-CINRYZE C1 INH): Three BAA | 1 |
| Untreated: One BAA | 1 |
| Untreated: Two BAA | 0 |
| Untreated: Three BAA | 5 |
| Treated (CINRYZE): Initial improvement | 2 |
| Treated (NON-CINRYZE C1 INH): Initial improvement | 1 |
| Untreated: Initial improvement | 6 |
| Treated (CINRYZE): Complete resolution | 2 |
| Treated (NON-CINRYZE C1 INH): Complete resolution | 1 |
| Untreated: Complete resolution | 6 |
Time to initial improvement (TII) was calculated from the time of study drug administration to initial symptom improvement. Time to complete resolution was defined as the time from the onset of attack to complete resolution of all symptoms. Time to initial improvement and time to complete resolution as assessed by CINRYZE, non-CINRYZE and untreated were reported.
| Hours | CINRYZE 1000 U |
|---|---|
| Treated (CINRYZE): TII | 13.38 (4.250 to 22.500) |
| Treated (NON-CINRYZE): TII | 6.42 (NA to NA) |
| Untreated: TII | 10.75 (8.750 to 118.000) |
| Treated (CINRYZE): Complete resolution | 40.67 (23.834 to 57.500) |
| Treated (NON-CINRYZE): Complete resolution | 9.00 (NA to NA) |
| Untreated: Complete resolution | 61.83 (11.000 to 152.000) |
The median time from onset of attack to time treated with CINRYZE was reported.
| Hours | CINRYZE 1000 U |
|---|---|
| Time From Onset of Attack to Time Treated by CINRYZE | 11.97 (3.050 to 20.884) |
Time to initial improvement was calculated from the time of study drug administration to initial symptom improvement. Median time from treatment with CINRYZE to initial improvement was reported.
| Hours | CINRYZE 1000 U |
|---|---|
| Time From Treatment With CINRYZE to Initial Improvement | 1.41 (1.200 to 1.617) |
Collected over From start of study drug administration up to Week 12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CINRYZE 1000 U | 0/8 (0%) | 2/8 (25%) | 7/8 (87.5%) |
| Event | CINRYZE 1000 U |
|---|---|
| Hereditary angioedemaCongenital, familial and genetic disorders | 1/8 |
| Acute myocardial infarctionCardiac disorders | 1/8 |
| Event | CINRYZE 1000 U |
|---|---|
| NasopharyngitisInfections and infestations | 3/8 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/8 |
| HeadacheNervous system disorders | 2/8 |
| Intervertebral disc disorderMusculoskeletal and connective tissue disorders | 1/8 |
| Abdominal painGastrointestinal disorders | 1/8 |
| ConstipationGastrointestinal disorders | 1/8 |
| Chest painGeneral disorders | 1/8 |
| Injection site painGeneral disorders | 1/8 |
| Seasonal allergyImmune system disorders | 1/8 |
| Herpes virus infectionInfections and infestations | 1/8 |
Intent-to-treat safety (ITT-S) set included participants who received any amount of investigational product.
| Age, Continuous(year) | CINRYZE 500 U | CINRYZE 1000 U | Total |
|---|---|---|---|
| Mean | — | 38.4 ± 7.27 | 38.4 ± 7.27 |
| Sex: Female, Male(Participants) | CINRYZE 500 U | CINRYZE 1000 U | Total |
|---|---|---|---|
| Female | — | 6 | 6 |
| Male | — | 2 | 2 |
| Ethnicity (NIH/OMB)(Participants) | CINRYZE 500 U | CINRYZE 1000 U | Total |
|---|---|---|---|
| Hispanic or Latino | — | 0 | 0 |
| Not Hispanic or Latino | — | 8 | 8 |
| Unknown or Not Reported | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | CINRYZE 500 U | CINRYZE 1000 U | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 |
| Asian | — | 8 | 8 |
| Native Hawaiian or Other Pacific Islander | — | 0 | 0 |
| Black or African American | — | 0 | 0 |
| White | — | 0 | 0 |
| More than one race | — | 0 | 0 |
| Unknown or Not Reported | — | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
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, Sap, Icf, Csr
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