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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02077192




Registration number
NCT02077192
Ethics application status
Date submitted
27/02/2014
Date registered
4/03/2014

Titles & IDs
Public title
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Scientific title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Secondary ID [1] 0 0
2013-005454-30
Secondary ID [2] 0 0
C-935788-049
Universal Trial Number (UTN)
Trial acronym
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

Experimental: Fostamatinib Disodium - Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day


Treatment: Drugs: Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1
Timepoint [1] 0 0
Up to 12 months
Primary outcome [2] 0 0
Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Duration of Platelet Response Based on Platelet Count and Rescue Medication
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count
Timepoint [2] 0 0
Up to 12 months

Eligibility
Key inclusion criteria
* Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
* Able and willing to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
* Poorly controlled hypertension during Study C935788-047 or Study C935788-048
* Significant infection, an acute infection such as influenza, or known inflammatory process

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/06/2020
Sample size
Target
Accrual to date
Final
123
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
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [6] 0 0
The Alfred - Melbourne
Recruitment hospital [7] 0 0
Perth Blood Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 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
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
Austria
State/province [8] 0 0
Vienna
Country [9] 0 0
Bulgaria
State/province [9] 0 0
BG
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Pleven
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Vratsa
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Czechia
State/province [14] 0 0
Brno
Country [15] 0 0
Czechia
State/province [15] 0 0
Ostrava-Poruba
Country [16] 0 0
Denmark
State/province [16] 0 0
DK
Country [17] 0 0
Hungary
State/province [17] 0 0
Pecs
Country [18] 0 0
Italy
State/province [18] 0 0
BO
Country [19] 0 0
Italy
State/province [19] 0 0
Udine
Country [20] 0 0
Netherlands
State/province [20] 0 0
NL
Country [21] 0 0
Norway
State/province [21] 0 0
Bergen
Country [22] 0 0
Norway
State/province [22] 0 0
Grålum
Country [23] 0 0
Poland
State/province [23] 0 0
Dolnoslaski
Country [24] 0 0
Poland
State/province [24] 0 0
PO
Country [25] 0 0
Poland
State/province [25] 0 0
Gdansk
Country [26] 0 0
Poland
State/province [26] 0 0
Kraków
Country [27] 0 0
Poland
State/province [27] 0 0
Lodz
Country [28] 0 0
Poland
State/province [28] 0 0
Lublin
Country [29] 0 0
Poland
State/province [29] 0 0
Opole
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Romania
State/province [31] 0 0
Bucuresti
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Valencia
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Essex
Country [36] 0 0
United Kingdom
State/province [36] 0 0
UK
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Canterbury
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Great Yarmouth
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Leeds
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Leicester
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Liverpool
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Oxford
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Stoke-on-Trent

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02077192