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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 is a Phase 3 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 35 participants.
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.
Interventions
- BIOLOGICAL Gammaplex, intravenous immunoglobulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00504075
The ClinicalTrials.gov registry entry for NCT00504075 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bio Products Laboratory, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gammaplex, intravenous immunoglobulin is the first listed.
NCT00504075 reports 0 study locations.
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.
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