Fostamatinib PASS in Adult Patients with cITP
Research type
Research Study
Full title
Post-Authorization Long Term Safety Surveillance Study of Fostamatinib in Adult Patients with Chronic Immune Thrombocytopenia (cITP) who are Refractory to Previous Treatments
IRAS ID
303201
Contact name
Ailbhe de Bhulbh
Contact email
Sponsor organisation
Instituto Grifols, S.A.
Clinicaltrials.gov Identifier
EUPAS42043, EU PAS Register number
Duration of Study in the UK
4 years, 8 months, 28 days
Research summary
Immune thrombocytopenic purpura (ITP) is a bleeding disorder in which the immune system destroys platelets, which are necessary for normal blood clotting. People with the disease have too few platelets in the blood. ITP occurs when certain immune system cells produce antibodies against platelets. The antibodies attach to the platelets and the body then destroys the platelets that carry the antibodies. In adults, ITP is often a long-term, or chronic, disease and is then called cITP.
Instituto Grifols, S.A. is a company who has developed a drug called Tavlesse® (or fostamatinib). Tavlesse® is a commercially available medicine that reduces the immune system’s destruction of platelets and so helps the platelet count to rise. It is used when other treatments have not worked.
Although Tavlesse® has been tested in clinical trials, it has been agreed with regulatory authorities in Europe that additional long-term safety data will be collected in a real-world setting. Safety data on participants’ experience with Tavlesse® will be collected from routine examinations and treatments prescribed by the participants’ doctors. Data will be collected for at least two years and up to a maximum of five years for each participant in the study.
At least 67 people who have cITP and live in the UK or the EU will participate in the study.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0221
Date of REC Opinion
27 Sep 2022
REC opinion
Further Information Favourable Opinion