Clinical trial NCT02076412: A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenic Purpura
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Stable Platelet Response of at Least 50,000/µL
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
timeFrame: Baseline to Week 12
measure: Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
timeFrame: Baseline to Week 24
measure: Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12
timeFrame: Baseline to Week 12
measure: Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24
timeFrame: Baseline to Week 24
measure: Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)
timeFrame: Baseline to Week 24
measure: Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland Division of Highland Medical PC
state: New York
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus Wiener Gebietskrankenkasse
state: AU
city: Wien
country: Austria
facility: Medizinische Universitaet Wien / AKH Wien
state: AU
city: Rankweil
country: Austria
facility: LKH Feldkirch at LKH Rankweil
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
state: BG
city: Vratsa
country: Bulgaria
facility: MHAT Hristo Botev, AD, Vratsa, First Internal Department
state: BG
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
state: CZ
city: Kyjov
country: Czechia
facility: Hospital Kyjov
state: CZ
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg (UKGM)
state: DE
city: Hannover
country: Germany
facility: Werlhof Institut GmbH
state: DE
city: Berlin
country: Germany
facility: Charit Berlin - Campus Benjamin Franklin
city: Duesseldorf
country: Germany
facility: Marien Hospital Duesseldorf
city: Essen
country: Germany
facility: Universittsklinikum Essen
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Fredrikstad
country: Norway
facility: Sykehuset Østfold Fredrikstad
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Szpital Uniwersytecki
city: Lodz
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Lekarski
city: Opole
country: Poland
facility: Szpital Wojewodzki w Opolu
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka
city: Warszawa
country: Poland
facility: Instytut Hematologii I Transfuzjologii
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie
state: Mures
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina, Hematologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea, Hematologie
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Universitariola Paz
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe de Valencia
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Rigel Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References:
citation: Cooper N, Altomare I, Thomas MR, Nicolson PLR, Watson SP, Markovtsov V, Todd LK, Masuda E, Bussel JB. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021 Apr 30;12:20406207211010875. doi: 10.1177/20406207211010875. eCollection 2021.