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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02076399




Registration number
NCT02076399
Ethics application status
Date submitted
26/02/2014
Date registered
3/03/2014

Titles & IDs
Public title
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
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
Secondary ID [1] 0 0
2013-005452-15
Secondary ID [2] 0 0
C-935788-047
Universal Trial Number (UTN)
Trial acronym
FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenic Purpura 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
From Week 14 to Week 24
Secondary outcome [1] 0 0
Number of Participants With Platelet Count = 50,000/µL at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Number of Participants With Platelet Count = 50,000/µL at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Platelet Count = 30,000/µL and = 20,000/µL Above Baseline in Subjects With Baseline Platelet Count of <15,000/µL at Week 12.
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Platelet Count = 30,000/µL and = 20,000/µL Above Baseline in Subjects With Baseline Platelet Count of <15,000/µL at Week 24.
Timepoint [4] 0 0
Baseline to Week 24
Secondary outcome [5] 0 0
Mean of the ITP Bleeding Score (IBLS)
Timepoint [5] 0 0
Assessed over the 24-week study period
Secondary outcome [6] 0 0
Mean of World Health Organization (WHO) Bleeding Scale
Timepoint [6] 0 0
Assessed over the 24-week study period

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinical diagnosis of autoimmune hemolytic anemia
* Uncontrolled or poorly controlled hypertension
* History of coagulopathy including prothrombotic conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/04/2016
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [7] 0 0
Frankston Hospital - Frankston
Recruitment hospital [8] 0 0
Dept of Haematology, The Alfred Hospital and Monash Medical Centre - Melbourne
Recruitment hospital [9] 0 0
Perth Blood Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Denmark
State/province [13] 0 0
DK
Country [14] 0 0
Denmark
State/province [14] 0 0
Aalborg
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Debrecen
Country [17] 0 0
Hungary
State/province [17] 0 0
Pecs
Country [18] 0 0
Italy
State/province [18] 0 0
Bologna
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Napoli
Country [21] 0 0
Italy
State/province [21] 0 0
Udine
Country [22] 0 0
Italy
State/province [22] 0 0
Vicenza
Country [23] 0 0
Netherlands
State/province [23] 0 0
NL
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Canterbury
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Essex
Country [26] 0 0
United Kingdom
State/province [26] 0 0
UK
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Leeds
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Leicester
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Manchester
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Newcastle-upon-Tyne
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Norfolk
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Oxford
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Stoke-on-Trent
Country [35] 0 0
United Kingdom
State/province [35] 0 0
West Bromwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Rigel Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rigel Pharmaceuticals, Inc.
Address 0 0
Rigel Pharmaceuticals,Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02076399