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

Primary Purpose

Immune Thrombocytopenic Purpura

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fostamatinib Disodium
Placebo
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hematology Oncology Associates of Rockland Division of Highland Medical PC
  • Hanusch-Krankenhaus Wiener Gebietskrankenkasse
  • Medizinische Universitaet Wien / AKH Wien
  • LKH Feldkirch at LKH Rankweil
  • Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
  • MHAT Hristo Botev, AD, Vratsa, First Internal Department
  • UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
  • UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology
  • Fakultni nemocnice Brno
  • Hospital Kyjov
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie
  • Universitaetsklinikum Giessen und Marburg (UKGM)
  • Werlhof Institut GmbH
  • Charit Berlin - Campus Benjamin Franklin
  • Marien Hospital Duesseldorf
  • Universittsklinikum Essen
  • Haukeland University Hospital
  • Sykehuset Østfold Fredrikstad
  • Uniwersyteckie Centrum Kliniczne
  • Szpital Uniwersytecki
  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
  • Specjalistyczny Gabinet Lekarski
  • Szpital Wojewodzki w Opolu
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
  • Instytut Hematologii I Transfuzjologii
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
  • Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie
  • Spitalul Clinic Colentina, Hematologie
  • Spitalul Clinic Coltea, Hematologie
  • Hospital Universitari Vall D'Hebron
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitariola Paz
  • Hospital Universitari i Politécnic La Fe de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Fostamatinib Disodium

Placebo

Arm Description

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

Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Platelet Count ≥ 50,000/µL at Week 12
Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Platelet Count ≥ 50,000/µL at Week 24
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.
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
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.
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.

Full Information

First Posted
February 26, 2014
Last Updated
January 24, 2019
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02076412
Brief Title
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fostamatinib Disodium
Arm Type
Experimental
Arm Description
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Arm Title
Placebo
Arm Type
Other
Arm Description
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Intervention Type
Drug
Intervention Name(s)
Fostamatinib Disodium
Other Intervention Name(s)
R935788, R788, Fostamatinib
Intervention Description
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet PO bid (morning and evening)
Primary Outcome Measure Information:
Title
Number of Participants With Stable Platelet Response of at Least 50,000/µL
Description
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
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Description
Platelet Count ≥ 50,000/µL at Week 12
Time Frame
Baseline to Week 12
Title
Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Description
Platelet Count ≥ 50,000/µL at Week 24
Time Frame
Baseline to Week 24
Title
Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24
Description
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
Time Frame
Baseline to Week 24
Title
Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)
Description
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.
Time Frame
Baseline to Week 24
Title
Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale
Description
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.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigel Pharmaceuticals, Inc.
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hematology Oncology Associates of Rockland Division of Highland Medical PC
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
City
Vienna
State/Province
AU
ZIP/Postal Code
1140
Country
Austria
Facility Name
Medizinische Universitaet Wien / AKH Wien
City
Wien
State/Province
AU
ZIP/Postal Code
1090
Country
Austria
Facility Name
LKH Feldkirch at LKH Rankweil
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
City
Sofia
State/Province
BG
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
MHAT Hristo Botev, AD, Vratsa, First Internal Department
City
Vratsa
State/Province
BG
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Fakultni nemocnice Brno
City
Brno
State/Province
CZ
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Hospital Kyjov
City
Kyjov
State/Province
CZ
ZIP/Postal Code
69733
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Universitaetsklinikum Giessen und Marburg (UKGM)
City
Giessen
State/Province
DE
ZIP/Postal Code
35392
Country
Germany
Facility Name
Werlhof Institut GmbH
City
Hannover
State/Province
DE
ZIP/Postal Code
30159
Country
Germany
Facility Name
Charit Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Marien Hospital Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Universittsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sykehuset Østfold Fredrikstad
City
Fredrikstad
ZIP/Postal Code
1606
Country
Norway
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpital Uniwersytecki
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Specjalistyczny Gabinet Lekarski
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Szpital Wojewodzki w Opolu
City
Opole
ZIP/Postal Code
45-064
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Instytut Hematologii I Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie
City
Targu Mures
State/Province
Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Spitalul Clinic Colentina, Hematologie
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Spitalul Clinic Coltea, Hematologie
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitariola Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitari i Politécnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33995988
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.
Results Reference
derived

Learn more about this trial

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

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