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NCT00220740 · ClinicalTrials.gov registry record · Phase 3
Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A Phase 3 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT00220740 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 117 participants.
The verdict
NCT00220740, a Phase 3 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Albumin (Human) 25%, United States Pharmacopeia (USP)
- DRUG Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00220740
The ClinicalTrials.gov registry entry for NCT00220740 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Albumin (Human) 25%, United States Pharmacopeia (USP) is the first listed.
NCT00220740 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00220740 about?
NCT00220740 is a clinical study titled "Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)". 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 fu...
What is the current status of trial NCT00220740?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2004-04. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00220740?
The interventions under investigation include: Albumin (Human) 25%, United States Pharmacopeia (USP) (DRUG), Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified (DRUG).
Who is sponsoring clinical trial NCT00220740?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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