Clinical trials allow us to research and develop new medicine and treatment options for patients. At Mount Sinai, we conduct hundreds of clinical trials each year. The liver thrombosis team is actively working on a clinical trial to compare the effectiveness of treatments for essential thrombocythemia patients.
Study Title: A Phase three, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy for Essential Thrombocythemia patients.
Summary: The goal of this study is to provide long-term safety and efficacy of P1101 in ET subjects, as compared to anagrelide. P1101 or ropeginterferon α-2b (P1101) drug substance is a mono-pegylated form of the P1040 drug intermediate (Proline-Interferon-α [IFNα-2b) that has been reacted with a 40 kDa branched PEG-aldehyde. Recent independent studies performed using peg-IFNα-2a in ET showed hematologic response rates that were comparable to standard interfereon-α, but with less associated toxicity.
The otal duration of study participation is approximately 14 months, with a screening period of 28 days, a treatment period of 12 months, and a follow-up period of 28 days. Subject visits will be scheduled every two weeks in both treatment arms.
Study PI, John Mascarenhas, MD,
firstname.lastname@example.org or MPN Clinical Trials Manager, Lonette Sandy,
email@example.com for more information.