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A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

Essential Thrombocythemia Clinical Trial

Official title:
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia

Clinical Trial Summary

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia

Clinical Trial Description

PharmaEssentia is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET constitutes a serious issue in modern hematology. Ropeginterferon alfa-2b-njft (P1101) may represent an effective, well-tolerated treatment with the ability to provide a deeper response and superior control of important blood parameters with the potential to alter the course of the disease and prevent progression to post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global Phase 3 clinical study, SURPASS ET. Enrolled patients will receive P1101 over 13 months followed by an extension period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05482971
Study type Interventional
Source PharmaEssentia
Contact Jewell Jessup, PhD
Phone 1-800-999-2449
Email clinicaltrials@pharmaessentia.com
Status Recruiting
Phase Phase 2
Start date September 29, 2022
Completion date December 31, 2026
View Details
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