A Phase 3 interventional study of Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by Grifols Therapeutics LLC. Completed at 32 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by Grifols Therapeutics LLC (part of Grifols) · Phase 3, Interventional, and Treatment
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Among 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States — 20 open to participants now, 25 under way, 10 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · United States.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, this one is the 13th largest by enrollment of the 42 interventional ones that give a count, is one of 2 that started in 2004, is one of 15 in phase 3, and was the 3rd 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 →20 of the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States are open now. Recruiting first, the newest first:
Kedrion S.p.A. · Sites in United States
Ages 18+
Kite, A Gilead Company · Sites in United States, Australia, Canada
Ages 18–75
Grifols Therapeutics LLC · Sites in United States, Czechia, Poland and 1 more country
Ages 18+
argenx · Sites in United States, Argentina, Austria and 22 more countries
Ages 18+
argenx · Sites in United States, Argentina, Australia and 28 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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.
55 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 1 4 · Phase 2 17 · Phase 3 16 · Phase 4 2
First in 1990; this study’s year is marked. 2 started in 2004.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 117 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 74 across the 42 interventional studies, 120 across the 12 observational. Of the 28 that completed or were terminated, 14 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 55 have an industry lead sponsor. The 10 most frequent:
This study is registered under Grifols Therapeutics LLC, one of the names counted as Grifols. Under that name alone:
Grifols Therapeutics LLC is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
Grifols has 2 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
10 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT06680037TG Therapeutics, Inc.A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders | 2026-12-01 |
Add all 10 to your calendar (.ics) → With an account.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.
110 subjects, 55 per treatment group, with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial. Patients will not be replaced if they discontinue prematurely.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
IGIV-C
Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Drug page: Immunoglobulins, Intravenous
2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Also known as: IGIV-C, IGIV-Chromatography (IGIV-C), 10%, Gamunex®, Gaminex®, IGIVnex, Intravenous Immunoglobulin (Human) (IGIV), Intravenous Immunoglobulin (Human), IVIG, IGIV, Intravenous Immune Globulin (Human), TAL-05-00004, Bay 41-1000, NDC13533-645-12, NDC13533-645-15, NDC13533-645-20, NDC13533-645-71, NDC13533-645-24
Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Also known as: Albumin (Human) 25%, USP, Plasbumin®-25, Plasbumin®-25 (Low Aluminum), TAL-05-00009, TAL-05-00025, Bay 34-9255, NDC 13533-684-16, NDC 13533-684-20, NDC 13533-684-71, NDC 13533-692-16, NDC 13533-692-20, NDC 13533-692-71
Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period
The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period. Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10. INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement. INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help
Time frame: 6 months
Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period
Mean changes in amplitude \[mV\] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)
Time frame: 6 months
Mean Change in Grip Strength During the Efficacy Period
Time frame: 6 months
Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period
Time frame: 6 months
The study was conducted at 31 study centers in USA, Poland, Argentina, Czech Republic, Canada, Mexico, Italy, Israel, Germany, and Serbia.
| Milestone | IGIV-C | Placebo |
|---|---|---|
| Started | 59 | 58 |
| Completed | 33 | 12 |
| Not completed | 26 | 46 |
| Withdrew: Entered rescue treatment with placebo | 23 | 0 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Entered rescue treatment with igiv-c | 0 | 45 |
| Milestone | IGIV-C | Placebo |
|---|---|---|
| Started | 45 | 23 |
| Completed | 26 | 5 |
| Not completed | 19 | 18 |
| Milestone | IGIV-C | Placebo |
|---|---|---|
| Started | 43 | 31 |
| Completed | 37 | 16 |
| Not completed | 6 | 15 |
The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period. Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10. INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement. INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help
| percentage of responders | IGIV-C | Placebo |
|---|---|---|
| Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period | 54.2 | 20.7 |
Mean changes in amplitude \[mV\] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)
| Millivolts | IGIV-C | Placebo |
|---|---|---|
| Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period | 0.69 ± 1.856 | 0.47 ± 2.291 |
| kilopascal | IGIV-C | Placebo |
|---|---|---|
| Dominant hand (IGIV-C n=57, Placebo n=58) | 13.175 ± 19.2935 | 1.489 ± 15.5742 |
| Non-dominant hand (IGIV-C n=58, Placebo n=58) | 13.316 ± 17.3526 | 4.261 ± 14.8959 |
| weeks | IGIV-C | Placebo |
|---|---|---|
| Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period | 21.89 ± 6.181 | 16.56 ± 8.543 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IGIV-C | — | 6/113 (5.3%) | 81/113 (71.7%) |
| Placebo | — | 8/95 (8.4%) | 25/95 (26.3%) |
| Event | IGIV-C | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 2/113 | 0/95 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/113 | 1/95 |
| Demyelinating polyneuropathyNervous system disorders | 0/113 | 1/95 |
| Back painMusculoskeletal and connective tissue disorders | 0/113 | 1/95 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/113 | 1/95 |
| Medical observation (for asthma)Investigations | 0/113 | 1/95 |
| Gastroenteritis viralInfections and infestations | 0/113 | 1/95 |
| Cerebrovascular accidentNervous system disorders | 0/113 | 1/95 |
| Deep vein thrombosisVascular disorders | 0/113 | 1/95 |
| PregnancyPregnancy, puerperium and perinatal conditions | 0/113 | 1/95 |
| Event | IGIV-C | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 34/113 | 8/95 |
| PyrexiaGeneral disorders | 14/113 | 0/95 |
| HypertensionVascular disorders | 10/113 | 4/95 |
| AstheniaGeneral disorders | 9/113 | 3/95 |
| ChillsGeneral disorders | 9/113 | 0/95 |
| Back painMusculoskeletal and connective tissue disorders | 8/113 | 3/95 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/113 | 1/95 |
| RashSkin and subcutaneous tissue disorders | 8/113 | 1/95 |
| NauseaGastrointestinal disorders | 7/113 | 3/95 |
| InfluenzaInfections and infestations | 6/113 | 2/95 |
| Age, Categorical(Participants) | IGIV-C | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 44 | 40 | 84 |
| >=65 years | 15 | 17 | 32 |
| Age, Continuous(years) | IGIV-C | Placebo | Total |
|---|---|---|---|
| Mean | 49.9 ± 17.31 | 53.3 ± 15.63 | 51.6 ± 16.51 |
| Sex: Female, Male(Participants) | IGIV-C | Placebo | Total |
|---|---|---|---|
| Female | 28 | 12 | 40 |
| Male | 31 | 46 | 77 |
| Region of Enrollment(participants) | IGIV-C | Placebo | Total |
|---|---|---|---|
| United States | 4 | 2 | 6 |
| Czech Republic | 7 | 6 | 13 |
| Mexico | 3 | 5 | 8 |
| Canada | 1 | 1 | 2 |
| Argentina | 8 | 7 | 15 |
| Poland | 15 | 15 | 30 |
| Israel | 8 | 7 | 15 |
| Germany | 2 | 3 | 5 |
| Italy | 6 | 6 | 12 |
| Macedonia, The Former Yugoslav Republic of | 5 | 6 | 11 |
| Baseline INCAT Score(units on a scale) | IGIV-C | Placebo | Total |
|---|---|---|---|
| Total Overall Disability Score | 4.2 ± 1.4 | 4.1 ± 1.5 | 4.2 ± 1.4 |
| Upper Extremity Disability Score | 2.3 ± 1.0 | 2.1 ± 1.0 | 2.2 ± 1.0 |
| Lower Extremity Disability Score | 1.9 ± 0.8 | 1.9 ± 1.1 | 1.9 ± 0.9 |
The record gives a start of Apr 2004, a primary completion of Jun 2006 and a completion of Jun 2006. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2015, 9 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Immunoglobulins, Intravenous
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →