C1131003 - PRIMARY IMMUNE THROMBOCYTOPENIA
Research type
Research Study
Full title
AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA
IRAS ID
1007458
Contact name
Barry Oemar
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-002897-19
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to evaluate the safety, tolerability and the response of the PF-06835375 study drug effect on platelet counts in adult participants with moderate to severe primary Immune Thrombocytopenia. This study will focus on participants with persistent (3 to 12 months) or chronic (>12 months) ITP. Each participant in the second cohort will receive one 18 mg subcutaneous (under the skin) injection once monthly for 4 months. The study will also look at the amount of study drug in the blood and how it is changed and removed from the body (pharmacokinetics) as well as immune cell depletion of circulating B cells and T follicular helper cells over time. This is a global, multicentre study. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic for about 28 weeks. Pfizer, Inc is funding the study.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0532
Date of REC Opinion
10 Oct 2023
REC opinion
Further Information Favourable Opinion