049 FIT (Fostamatinib for Immune Thrombocytopenia) Extension Study
Research type
Research Study
Full title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
IRAS ID
152584
Contact name
Adrian Newland
Contact email
Sponsor organisation
Rigel Pharmaceuticals, Inc.
Eudract number
2013-005454-30
Clinicaltrials.gov Identifier
Research summary
This is an extension study investigating the study drug, fostamatinib, an experimental drug that is being tested for patients with immune thrombocytopenic purpura (ITP).
Experimental means that the study drug is not yet approved
Immune thrombocytopenic purpura (ITP) is a bleeding disorder that results when a person's platelets are destroyed by their immune system. Platelets are necessary for normal blood clotting.
The causes and risk factors of ITP are unknown, except if the cause of ITP is a consequence of a viral infection, for example in children.
Symptoms of ITP include nosebleeds or bleeding in the mouth, abnormal menstruation, bleeding into the skin causing red spots (petechial rash). ITP patients also bruise easily.
ITP affects both adults and children, equally affecting boys and girls but more women than men.
A patient’s ITP is considered to be persistent or chronic if their platelet count has regularly been below 30,000/µL for at least 3 months and they don’t have any other conditions that are causing their platelets to be destroyed.
The primary objective of this study is to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP. Additionally, to establish the long-term efficacy of fostamatinib in achieving and maintaining a stable platelet count in subjects who complete the treatment phase of Study C935788-047 and to assess the pharmacokinetic (PK) profile of fostamatinib in subjects with persistent/chronic ITP.
Approximately 150 adult patients with persistent/chronic ITP will take part in this study UK and worldwide.
Subjects must have completed the Week 24 evaluation of Study C935788-047 or have discontinued early (after Week 12) due to lack of response.
The study will consist of 26 visits over a 2-year period.
A patient information sheet describing the study will be provided.
Participation in this study is entirely voluntary. Signed and dated informed consent will be obtained from each participant before any study procedures are performed.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1060
Date of REC Opinion
28 Nov 2014
REC opinion
Further Information Favourable Opinion