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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)
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Scientific title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
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Secondary ID [1]
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2013-005454-30
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Secondary ID [2]
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C-935788-049
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Universal Trial Number (UTN)
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Trial acronym
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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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0
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Autoimmune diseases
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Blood
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0
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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
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
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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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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
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Assessment method [1]
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Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
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Timepoint [1]
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Up to 12 months
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Primary outcome [2]
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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
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Assessment method [2]
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A within-subject, between-study comparison of platelet counts for subjects who were previously treated with placebo in one of the prior studies (C788-047 or C788-048) was prospectively defined in the protocol (version 2). Achievement of platelet response by 12 weeks and maintenance of platelet response for 12 weeks was analyzed among subjects who had been randomized to placebo in one of the prior studies (C788-047 or C788-048). Treated Population was defined as all enrolled and treated subjects.
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Timepoint [2]
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Up to 12 months
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Secondary outcome [1]
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Duration of Platelet Response Based on Platelet Count and Rescue Medication
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Assessment method [1]
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The duration of platelet response was defined as the time from when the subject first achieved a platelet count of at least 50,000/µL, until the first of 2 visits with platelet counts \< 50,000/µL that were at least 4 weeks apart without an intervening visit with a platelet count less than equal to (\<=) 50,000/µL unrelated to rescue therapy. Duration of platelet response was analyzed using the Kaplan-Meier method. Treated Population was defined as all enrolled and treated subjects. Here, a number of subjects analyzed included all subjects evaluable for this endpoint.
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Timepoint [1]
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Up to 12 months
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Secondary outcome [2]
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Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count
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Assessment method [2]
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The percentage of subjects in whom a reduction in the dose of concomitant ITP therapy could be achieved while maintaining an adequate platelet count, the reduction event was clarified to apply only to reductions in the dose of concomitant ITP therapy occurring within a period of platelet response and the reduction event was not be prompted by an adverse event.
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Timepoint [2]
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Up to 12 months
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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
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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
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/10/2014
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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
2/06/2020
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Sample size
Target
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Accrual to date
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Final
123
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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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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment hospital [5]
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Launceston General Hospital - Launceston
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Recruitment hospital [6]
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The Alfred - Melbourne
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Recruitment hospital [7]
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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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2170 - Liverpool
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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7250 - Launceston
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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Arizona
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Bucuresti
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London
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Oxford
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Stoke-on-Trent
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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 primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
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Trial website
https://clinicaltrials.gov/study/NCT02077192
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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.
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/92/NCT02077192/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT02077192/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02077192