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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02076399
Registration number
NCT02076399
Ethics application status
Date submitted
26/02/2014
Date registered
3/03/2014
Date last updated
12/02/2019
Titles & IDs
Public title
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
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Scientific title
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
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Secondary ID [1]
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2013-005452-15
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Secondary ID [2]
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C-935788-047
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Universal Trial Number (UTN)
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Trial acronym
FIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenic Purpura
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fostamatinib disodium
Treatment: Drugs - Placebo
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.
Other: Placebo - Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Treatment: Drugs: Fostamatinib disodium
Fostamatinib (100 mg PO bid or 150 mg PO bid)
Treatment: Drugs: Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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
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Timepoint [1]
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From Week 14 to Week 24
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Secondary outcome [1]
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Number of Participants With Platelet Count = 50,000/µL at Week 12
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Assessment method [1]
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Platelet Count = 50,000/µL at Week 12
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Number of Participants With Platelet Count = 50,000/µL at Week 24
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Assessment method [2]
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Platelet Count = 50,000/µL at Week 24
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Platelet Count = 30,000/µL and = 20,000/µL Above Baseline in Subjects With Baseline Platelet Count of <15,000/µL at Week 12.
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Week 12
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Secondary outcome [4]
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Platelet Count = 30,000/µL and = 20,000/µL Above Baseline in Subjects With Baseline Platelet Count of <15,000/µL at Week 24.
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Week 24
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Secondary outcome [5]
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Mean of the ITP Bleeding Score (IBLS)
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Assessment method [5]
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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.
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Timepoint [5]
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Assessed over the 24-week study period
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Secondary outcome [6]
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Mean of World Health Organization (WHO) Bleeding Scale
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Assessment method [6]
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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.
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Timepoint [6]
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Assessed over the 24-week study period
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinical diagnosis of autoimmune hemolytic anemia
- Uncontrolled or poorly controlled hypertension
- History of coagulopathy including prothrombotic conditions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/04/2016
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Sample size
Target
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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St George Hospital - Kogarah
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
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Launceston General Hospital - Launceston
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Recruitment hospital [7]
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Frankston Hospital - Frankston
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Recruitment hospital [8]
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Dept of Haematology, The Alfred Hospital and Monash Medical Centre - Melbourne
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Recruitment hospital [9]
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Perth Blood Institute - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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7250 - Launceston
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Recruitment postcode(s) [7]
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3199 - Frankston
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Indiana
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Maryland
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New York
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North Carolina
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Ohio
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DK
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Denmark
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Aalborg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Italy
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Napoli
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Italy
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Udine
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Italy
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Canterbury
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Essex
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Leicester
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Manchester
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Norfolk
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Oxford
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Stoke-on-Trent
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West Bromwich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Rigel Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02076399
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rigel Pharmaceuticals, Inc.
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Address
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Rigel Pharmaceuticals,Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02076399
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