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NCT02473965 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis
A Phase 2 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT02473965: Completed Phase 2 study, sponsored by Grifols Therapeutics.
NCT02473965 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02473965, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia Gravis (MG).
Primary Outcome
The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. Subjects who discontinued the study early with adverse outcomes related to MG were considered as not achieving a 50% or greater reduction. The missing dose reduction at Week 39 was imputed using the worst observation carried forward (WOCF) method. For subjects who did not have CS dose
Interventions
- DRUG Placebo
- DRUG IGIV-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-06 |
| Est. Completion | 2019-02 |
| Phase | Phase 2 |
What the finished NCT02473965 record still lists
NCT02473965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02473965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02473965 about?
NCT02473965 is a clinical study titled "Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis". This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia Gravis (MG).
What is the current status of trial NCT02473965?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2015-06. Estimated completion is 2019-02.
What interventions are being tested in trial NCT02473965?
The interventions under investigation include: Placebo (DRUG), IGIV-C (DRUG).
Who is sponsoring clinical trial NCT02473965?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02473965's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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