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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: Completed Phase 3 study, sponsored by Grifols Therapeutics.

NCT00220740 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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

Interventions

  • DRUG Albumin (Human) 25%, United States Pharmacopeia (USP)
  • DRUG Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2004-04
Est. Completion 2006-06
Phase Phase 3
Grifols Therapeutics

34 total trials

What the finished NCT00220740 record still lists

NCT00220740 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 2 interventions - of which Albumin (Human) 25%, United States Pharmacopeia (USP) is the first listed.

NCT00220740 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00220740's enrollment target sits among peer trials

117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00220740, the US trial registry maintained by the National Library of Medicine. NCT00220740 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.