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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
Date last updated
11/12/2023

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
Not applicable
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
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
Trial website
https://clinicaltrials.gov/study/NCT02077192
Trial related presentations / publications
Cooper N, Altomare I, Thomas MR, Nicolson PLR, Watson SP, Markovtsov V, Todd LK, Masuda E, Bussel JB. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021 Apr 30;12:20406207211010875. doi: 10.1177/20406207211010875. eCollection 2021.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02077192