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NCT02076412 · ClinicalTrials.gov registry record · Phase 3
A Efficacy and Safety Study of Fostamatinib 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
- 74
- Enrollment target
- 20
- Study locations
NCT02076412: Completed Phase 3 study of Immune Thrombocytopenic Purpura, sponsored by Rigel Pharmaceuticals.
NCT02076412 is a Phase 3 study of Immune Thrombocytopenic Purpura that has completed, run by Rigel Pharmaceuticals. The registered enrollment target is 74 participants, below the 111-participant average among 3 other Immune Thrombocytopenic Purpura trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02076412, a Phase 3 study of Immune Thrombocytopenic Purpura, has completed, sponsored by Rigel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
Primary Outcome
Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fostamatinib Disodium
Study Locations (20)
Other
- LKH Feldkirch at LKH Rankweil - Rankweil
- UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology - Pleven
- UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology - Sofia
- Fakultni nemocnice Ostrava - Ostrava-Poruba
- Fakultni nemocnice Kralovske Vinohrady - Prague
- Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie - Prague
- Charit Berlin - Campus Benjamin Franklin - Berlin
- Marien Hospital Duesseldorf - Düsseldorf
- Universittsklinikum Essen - Essen
- Haukeland University Hospital - Bergen
- Sykehuset Østfold Fredrikstad - Fredrikstad
AU
- Medizinische Universitaet Wien / AKH Wien - Vienna
- Hanusch-Krankenhaus Wiener Gebietskrankenkasse - Vienna
BG
- Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology; - Sofia
- MHAT Hristo Botev, AD, Vratsa, First Internal Department - Vratsa
CZ
- Fakultni nemocnice Brno - Brno
- Hospital Kyjov - Kyjov
DE
- Universitaetsklinikum Giessen und Marburg (UKGM) - Giessen
- Werlhof Institut GmbH - Hanover
New York
- Hematology Oncology Associates of Rockland Division of Highland Medical PC - Nyack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-08 |
| Phase | Phase 3 |
What the finished NCT02076412 record still lists
NCT02076412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 111-participant average among 3 other Immune Thrombocytopenic Purpura trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Immune Thrombocytopenic Purpura appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02076412 names 20 study sites across 6 states, led by Other, AU, BG.
Frequently Asked Questions
What is clinical trial NCT02076412 about?
NCT02076412 is a clinical study titled "A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)". The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
What is the current status of trial NCT02076412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2015-01. Estimated completion is 2016-08.
What conditions does trial NCT02076412 study?
This clinical trial studies the following conditions: Immune Thrombocytopenic Purpura.
What interventions are being tested in trial NCT02076412?
The interventions under investigation include: Placebo (DRUG), Fostamatinib Disodium (DRUG).
Who is sponsoring clinical trial NCT02076412?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02076412 being conducted?
This trial has 20 study locations across New York, AU, BG, CZ, DE. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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