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NCT02077192 · ClinicalTrials.gov registry record · Phase 3
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
A Phase 3 study of Immune Thrombocytopenic Purpura, sponsored by Rigel Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT02077192: Completed Phase 3 study of Immune Thrombocytopenic Purpura, sponsored by Rigel Pharmaceuticals.
NCT02077192 is a Phase 3 study of Immune Thrombocytopenic Purpura that has completed, run by Rigel Pharmaceuticals. The registered enrollment target is 123 participants, above the 95-participant average among 3 other Immune Thrombocytopenic Purpura trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02077192, a Phase 3 study of Immune Thrombocytopenic Purpura, has completed, sponsored by Rigel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
Primary Outcome
Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
Conditions Studied
Interventions
- DRUG Fostamatinib Disodium
Study Locations (20)
New South Wales
- Concord Repatriation General Hospital - Concord
- Liverpool Hospital - Liverpool
- Prince of Wales Hospital - Randwick
- Westmead Hospital - Westmead
Other
- Hanusch-Krankenhaus Wiener Gebietskrankenkasse - Vienna
- UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology - Pleven
- UMHAT Aleksandrovska, EAD - Sofia
New York
- Weill Cornell Medical College/New York Presbyterian Hospital - New York
- Weill Cornell Medicine - New York
North Carolina
- East Carolina University, Brody School of Medicine - Greenville
- W.G. "Bill" Hefner VA Medical Center - Salisbury
Arizona
- Arizona Oncology Associates - Tucson
Illinois
- Bleeding & Clotting Disorders Institute - Peoria
Indiana
- Horizon Oncology Research, Inc - Lafayette
Maryland
- Center for Cancer and Blood Disorders - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2014-10 |
| Est. Completion | 2020-06-02 |
| Phase | Phase 3 |
What the finished NCT02077192 record still lists
NCT02077192 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, above the 95-participant average among 3 other Immune Thrombocytopenic Purpura trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Immune Thrombocytopenic Purpura appearing as the primary indexed condition, and to 1 intervention - of which Fostamatinib Disodium is the first listed.
NCT02077192 names 20 study sites across 13 states, led by New South Wales, Other, New York.
Frequently Asked Questions
What is clinical trial NCT02077192 about?
NCT02077192 is a clinical study titled "Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)". The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
What is the current status of trial NCT02077192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2014-10. Estimated completion is 2020-06-02.
What conditions does trial NCT02077192 study?
This clinical trial studies the following conditions: Immune Thrombocytopenic Purpura.
What interventions are being tested in trial NCT02077192?
The interventions under investigation include: Fostamatinib Disodium (DRUG).
Who is sponsoring clinical trial NCT02077192?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02077192 being conducted?
This trial has 20 study locations across Arizona, Illinois, Indiana, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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