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Sponsored by: |
Talecris Biotherapeutics |
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Information provided by: | Talecris Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00220740 |
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 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.
Condition | Intervention | Phase |
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Drug: Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified Drug: Albumin (Human) 25%, USP |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy |
Enrollment: | 117 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2006 |
Arms | Assigned Interventions |
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Group 1: Experimental
IGIV-C
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Drug: Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified
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
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Group 2: Placebo Comparator |
Drug: Albumin (Human) 25%, USP
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
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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.
Eligible subjects will be randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) ideally over 2-4 days or matching placebo.
Thereafter, study drug infusion (IGIV-C or matching 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. Patient's functional disability will be measured using the INCAT disability score at baseline, day 16, and at each study visit scheduled every 3 weeks for 6 months. If the INCAT score worsens by ≥1 point at any time between day 16 and month 6 (not including the month 6 visit) relative to baseline, the subject will be immediately crossed over to the other study drug. Subjects whose INCAT upper extremity score changes from 0 to 1 or from 1 to 0 will have an adjusted INCAT score calculated where this upper extremity change is not incorporated into the adjusted score.
Any subject with an adjusted INCAT score change of 0 will be deemed a stable patient and will be crossed over at week 6.
Upon entering the crossover period, subjects will receive either IGIV-C at a dose of 2 g/kg bw ideally over 2-4 days or matching placebo. Thereafter, a study drug infusion (IGIV-C or matching 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. A subject will be terminated from the study any time between day 16 and 6 months during the crossover period if the INCAT score fails to improve by ≥1 point relative to INCAT score at time of crossover. Stable subjects who crossed over at Week 6 must remain in the Crossover Treatment Period for 3 weeks before being considered for withdrawal (due to lack of improvement). Any subject who has been crossed-over to the alternate study drug will be deemed a treatment failure for the primary efficacy analysis.
Randomization will be within each center. Eight randomization numbers, which constitutes one or more full random blocks, will be assigned to each center. A random number will be assigned to subjects in ascending order.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Norman Latov, MD | Columbia University |
Study ID Numbers: | 100538 |
Study First Received: | September 13, 2005 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00220740 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Czech Republic: State Institute for Drug Control; Italy: Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; Poland: Ministry of Health; Israel: Israeli Health Ministry Pharmaceutical Administration; Germany: Federal Institute for Drugs and Medical Devices; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Immunoglobulin G |
Autoimmune Diseases Immunologic Factors Demyelinating Diseases Glycine Polyradiculoneuropathy Polyneuropathies Chronic Inflammatory Demyelinating Polyneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Antibodies Neuromuscular Diseases Immunoglobulins, Intravenous Peripheral Nervous System Diseases Immunoglobulin G Rho(D) Immune Globulin Autoimmune Diseases of the Nervous System Immunoglobulins |
Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Polyradiculoneuropathy Physiological Effects of Drugs Nervous System Diseases Polyneuropathies Pharmacologic Actions |
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Antibodies Neuromuscular Diseases Immunoglobulins, Intravenous Peripheral Nervous System Diseases Rho(D) Immune Globulin Autoimmune Diseases of the Nervous System Immunoglobulins |