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

Immune Thrombocytopenic Purpura Clinical Trial

— FIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076412
• Other study ID #: C-935788-048
• Secondary ID: 2013-005453-76
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
• Placebo
Placebo tablet PO bid (morning and evening)

Locations

Country	Name	City	State
Austria	LKH Feldkirch at LKH Rankweil	Rankweil
Austria	Hanusch-Krankenhaus Wiener Gebietskrankenkasse	Vienna	AU
Austria	Medizinische Universitaet Wien / AKH Wien	Wien	AU
Bulgaria	UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology	Pleven
Bulgaria	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	UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology	Sofia
Bulgaria	MHAT Hristo Botev, AD, Vratsa, First Internal Department	Vratsa	BG
Czechia	Fakultni nemocnice Brno	Brno	CZ
Czechia	Hospital Kyjov	Kyjov	CZ
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie	Praha 2
Germany	Charit Berlin - Campus Benjamin Franklin	Berlin
Germany	Marien Hospital Duesseldorf	Duesseldorf
Germany	Universittsklinikum Essen	Essen
Germany	Universitaetsklinikum Giessen und Marburg (UKGM)	Giessen	DE
Germany	Werlhof Institut GmbH	Hannover	DE
Norway	Haukeland University Hospital	Bergen
Norway	Sykehuset Østfold Fredrikstad	Fredrikstad
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Szpital Uniwersytecki	Krakow
Poland	Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi	Lodz
Poland	Specjalistyczny Gabinet Lekarski	Lublin
Poland	Szpital Wojewodzki w Opolu	Opole
Poland	Wojewodzki Szpital Specjalistyczny im. J. Korczaka	Slupsk
Poland	Instytut Hematologii I Transfuzjologii	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw	Wroclaw
Romania	Spitalul Clinic Colentina, Hematologie	Bucuresti
Romania	Spitalul Clinic Coltea, Hematologie	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie	Targu Mures	Mures
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitariola Paz	Madrid
Spain	Hospital Universitari i Politécnic La Fe de Valencia	Valencia
United States	Hematology Oncology Associates of Rockland Division of Highland Medical PC	Nyack	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Czechia,  Germany,  Norway,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Stable Platelet Response of at Least 50,000/µL	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	Baseline to Week 24
Secondary	Number of Participants With Platelet Count = 50,000/µL at Week 12	Platelet Count = 50,000/µL at Week 12	Baseline to Week 12
Secondary	Number of Participants With Platelet Count = 50,000/µL at Week 24	Platelet Count = 50,000/µL at Week 24	Baseline to Week 24
Secondary	Number of Participants With Platelet Count = 30,000/µL and at Least 20,000/µL Above Baseline at Week 12	Among subjects with a baseline platelet count < 15,000/µL, achievement of a count = 30,000/µL and at least 20,000/µL above baseline at Week 12.	Baseline to Week 12
Secondary	Number of Participants With Platelet Count = 30,000/µL and at Least 20,000/µL Above Baseline at Week 24	Among subjects with a baseline platelet count < 15,000/µL, achievement of a count = 30,000/µL and at least 20,000/µL above baseline at Week 24	Baseline to Week 24
Secondary	Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)	The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data.; The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.	Baseline to Week 24
Secondary	Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale	The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data.; The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint.	Baseline to Week 24