A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP) (FIT)

January 24, 2019 updated by: Rigel Pharmaceuticals

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Melbourne, Victoria, Australia, 3004
        • Dept of Haematology, The Alfred Hospital and Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Perth Blood Institute
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences Corporation
      • Ottawa, Ontario, Canada, K1 H8L6
        • Ottawa Hospital Research Institute
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital
  • Denmark
      • Aalborg, Denmark, 9000
        • Aarhus University Hospital
    • DK
      • Herlev, DK, Denmark, 2730
        • Herlev Hospital University of Copenhagen, Department of Hematology L124
      • Odense C, DK, Denmark, DK-5000
        • Dept. of Haematology, Odense University Hospital
      • Roskilde, DK, Denmark, 4000
        • Hematological department, Roskilde Hospital
  • Hungary
      • Budapest, Hungary, H-1083
        • Semmelweis University 1st
      • Debrecen, Hungary, H-1083
        • University of Debrecen
      • Pecs, Hungary, H-7624
        • Pécs University
  • Italy
      • Bologna, Italy, 40138
        • Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna
      • Milano, Italy, 20132
        • Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia
      • Napoli, Italy, 80131
        • Universita Federico II di Napoli
      • Udine, Italy, 33100
        • OspedaleCivile-ClinicaEmatologica/PUGD
      • Vicenza, Italy
        • ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza
  • Netherlands
    • NL
      • Haag, NL, Netherlands, 2545 CH
        • Haga ziekenhuis
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St. James's Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, E1 2ES
        • Royal London Hospital
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital, Catherine Lewis Centre
      • London, United Kingdom, WC1E 6HX
        • University College Hospital
      • Manchester, United Kingdom, M139WL
        • Manchester Royal Infirmary
      • Newcastle-upon-Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Norfolk, United Kingdom, NR31 6LA
        • James Paget University Hospital
      • Oxford, United Kingdom, OX3 9BQ
        • Oxford University Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
      • West Bromwich, United Kingdom, B71 4HJ
        • Sandwell General Hospital
    • Canterbury
      • Kent, Canterbury, United Kingdom, CT1 3NG
        • Kent & Canterbury Hospital
    • Essex
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Colchester General Hospital
    • UK
      • Liverpool, UK, United Kingdom, L78XP
        • Royal Liverpool University Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Arizona Oncology Associates
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California
    • Florida
      • Lakeland, Florida, United States, 33805-1965
        • Lakeland Regional Cancer Center
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Bleeding & Clotting Disorders Institute
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Research, Inc
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center For Cancer And Blood Disorders
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College/New York Presbyterian Hospital
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Pitt County Memorial Hospital
      • Salisbury, North Carolina, United States, 28144
        • Bill Hefner VA Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center LLC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fostamatinib Disodium
Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.
Drug: Fostamatinib disodium
Fostamatinib (100 mg PO bid or 150 mg PO bid)
Other Names:
  • R935788
  • Fostamatinib
  • R788
Other: Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Drug: Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)
Time Frame: From Week 14 to Week 24
A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24
From Week 14 to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Time Frame: Week 12
Platelet Count ≥ 50,000/µL at Week 12
Week 12
Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Time Frame: Week 24
Platelet Count ≥ 50,000/µL at Week 24
Week 24
Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12.
Time Frame: Baseline to Week 12
Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12.
Baseline to Week 12
Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24.
Time Frame: Baseline to Week 24
Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24.
Baseline to Week 24
Mean of the ITP Bleeding Score (IBLS)
Time Frame: Assessed over the 24-week study period

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.
Assessed over the 24-week study period
Mean of World Health Organization (WHO) Bleeding Scale
Time Frame: Assessed over the 24-week study period

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.
Assessed over the 24-week study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2014

Primary Completion (Actual)

April 21, 2016

Study Completion (Actual)

April 21, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-935788-047
  • 2013-005452-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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