Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH)
Identifying a safe and tolerated dose of Imatinib for patients with Pulmonary Arterial Hypertension (PAH)
Martin R. Wilkins
Imperial College London
Duration of Study in the UK
4 years, 0 months, 1 days
Pulmonary arterial hypertension (PAH) is a rare condition in which a narrowing of blood vessels carrying blood through the lungs increases resistance to blood flow, putting an increased pressure load on the heart. While current treatments relieve some of the symptoms, they do not stop or reverse the disease and patients die prematurely of heart failure.
Imatinib is a medicine licensed for some types of cancer. A previous Phase 3 study has shown that imatinib can have beneficial effects in PAH on exercise capacity and blood flow, even when added to existing treatments. However, there have been concerns about is safety and tolerability. The purpose of this study is to identify a safe and tolerated dose of imatinib as a treatment for patients with PAH and the genotype of patients most likely to benefit from it.
The first part of the study will identify a maximal tolerate dose (MTD) in the dose range 100mg to 400mg daily. The second part will evaluate the efficacy of this MTD at 24 weeks by measuring the change in resistance to blood flow through the lungs. UP to 43 patients will be required. The results will be interpreted according to the genotype of the patient.
South Central - Berkshire B Research Ethics Committee
Date of REC Opinion
28 Jul 2020
Further Information Favourable Opinion