A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Completed · Phase 3 · Has a placebo group

Conditions studied: Immune Thrombocytopenic Purpura

In brief

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Key facts

Study ID

NCT02076412

Run by

Rigel Pharmaceuticals

People needed

74

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of persistent/chronic ITP for at least 3 months
• Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

You may not qualify if…

• Clinical diagnosis of autoimmune hemolytic anemia
• Uncontrolled or poorly controlled hypertension
• History of coagulopathy including prothrombotic conditions

Where it is running

• Hematology Oncology Associates of Rockland Division of Highland Medical PC — Nyack, New York, United States
• Medizinische Universitaet Wien / AKH Wien — Vienna, AU, Austria
• Hanusch-Krankenhaus Wiener Gebietskrankenkasse — Vienna, AU, Austria
• LKH Feldkirch at LKH Rankweil — Rankweil, Austria
• Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology; — Sofia, BG, Bulgaria
• MHAT Hristo Botev, AD, Vratsa, First Internal Department — Vratsa, BG, Bulgaria
• UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology — Pleven, Bulgaria
• UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology — Sofia, Bulgaria
• Fakultni nemocnice Brno — Brno, CZ, Czechia
• Hospital Kyjov — Kyjov, CZ, Czechia
• Fakultni nemocnice Ostrava — Ostrava-Poruba, Czechia
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
• Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie — Prague, Czechia
• Universitaetsklinikum Giessen und Marburg (UKGM) — Giessen, DE, Germany
• Werlhof Institut GmbH — Hanover, DE, Germany
• Charit Berlin - Campus Benjamin Franklin — Berlin, Germany
• Marien Hospital Duesseldorf — Düsseldorf, Germany
• Universittsklinikum Essen — Essen, Germany
• Haukeland University Hospital — Bergen, Norway
• Sykehuset Østfold Fredrikstad — Fredrikstad, Norway
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Szpital Uniwersytecki — Krakow, Poland
• Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi — Lodz, Poland
• Specjalistyczny Gabinet Lekarski — Lublin, Poland
• Szpital Wojewodzki w Opolu — Opole, Poland

Full record on ClinicalTrials.gov

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