047 FIT (Fostamatinib for Immune Thrombocytopenia) Study
Research type
Research Study
Full title
A Phase 3, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
IRAS ID
152516
Contact name
Adrian Newland
Contact email
Sponsor organisation
Rigel Pharmaceuticals, Inc.
Eudract number
2013-005452-15
Clinicaltrials.gov Identifier
Research summary
This is a medical research 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 purpose of this research study is to see how effective fostamatinib is at increasing a patient’s platelet count, by measuring whether the number of platelets they have increases when they take the study drug.
Following screening, patients will be randomised to one of two treatment groups fostamatinib or matching placebo (2:1 ratio)
Approximately 75 adult patients with persistent/chronic ITP will take part in this study and will be recruited from about 40 study sites, located in the UK and worldwide.
Patients will attend for 16 study visits over a 30 week period.
Adults must be 18 years of age to participate. Children will not be participating.
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/1059
Date of REC Opinion
11 Sep 2014
REC opinion
Further Information Favourable Opinion