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

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ClinicalTrials.gov Identifier: NCT02076399
Recruitment Status : Completed
First Posted : March 3, 2014
Results First Posted : January 11, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 26, 2014
First Posted Date  ICMJE March 3, 2014
Results First Submitted Date  ICMJE October 15, 2018
Results First Posted Date  ICMJE January 11, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE July 14, 2014
Actual Primary Completion Date April 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2014)
Stable platelet response of at least 50,000/µL [ Time Frame: Baseline to Week 24 ]
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.
Change History Complete list of historical versions of study NCT02076399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Number of Participants With Platelet Count ≥ 50,000/µL at Week 12 [ Time Frame: Week 12 ]
    Platelet Count ≥ 50,000/µL at 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
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenic Purpura
Intervention  ICMJE
  • Drug: Fostamatinib disodium
    Fostamatinib (100 mg PO bid or 150 mg PO bid)
    Other Names:
    • R935788
    • R788
    • Fostamatinib
  • Drug: Placebo
    Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fostamatinib disodium
  • Placebo
    Placebo tablet PO bid (morning and evening) over the course of 24 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2017)
76
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2014)
75
Actual Study Completion Date  ICMJE April 21, 2016
Actual Primary Completion Date April 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Hungary,   Italy,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02076399
Other Study ID Numbers  ICMJE C-935788-047
2013-005452-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rigel Pharmaceuticals
Study Sponsor  ICMJE Rigel Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rigel Pharmaceuticals, Inc. Rigel Pharmaceuticals, Inc.
PRS Account Rigel Pharmaceuticals
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP