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NCT00504075 · ClinicalTrials.gov registry record · Phase 3
A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
A Phase 3 study, sponsored by Bio Products Laboratory.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT00504075: Completed Phase 3 study, sponsored by Bio Products Laboratory.
NCT00504075 is a Phase 3 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00504075, a Phase 3 study, has completed, sponsored by Bio Products Laboratory.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response \>60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.
Primary Outcome
The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10\^9/L by Day 9.
Interventions
- BIOLOGICAL Gammaplex, intravenous immunoglobulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT00504075 record still lists
NCT00504075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Gammaplex, intravenous immunoglobulin is the first listed.
NCT00504075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00504075 about?
NCT00504075 is a clinical study titled "A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)". To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response \>60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.
What is the current status of trial NCT00504075?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2007-09. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00504075?
The interventions under investigation include: Gammaplex, intravenous immunoglobulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00504075?
This trial is sponsored by Bio Products Laboratory, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00504075's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 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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