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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 Details

This clinical trial is designed for men and women with Essential thrombocythemia (ET) and either need to start with therapy to reduce their blood counts, or their current therapy is not sufficiently controlling their disease.
   
The purpose of this study is to evaluate if the study drug, P1101 (Ropeginterferon alfa-2b-njft) can normalize blood counts and the safety of P1101. 
   
Ropeginterferon alfa-2b-njft (P1101) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of polycythemia vera (PV), but is considered investigational in this study which means it has not yet been approved for ET.

Ropeginterferon alfa-2b-njft (P1101) will be administered subcutaneously every 2 weeks. Participants will also need to come into the office regularly to have their vital signs taken, undergo clinical safety laboratory tests, physical examinations, Echocardiogram (ECHO), and other tests as required.
   
Total study participation is expected to last about 15 months.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with Essential Thrombocythemia (ET) 
  2. Participants must not have a history of major organ transplant.

 Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2304025940

ClinicalTrials.gov:

NCT05482971

Sponsor:

A22-301

Status

Open to Enrollment

Age Group

Adult

Sponsor