ECLIPSE PV / A22-203

Recruiting at26 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: PharmaEssentia

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a medication called ropeginterferon alfa-2b-njft in adults with polycythemia vera, a type of blood cancer. The goal is to see how well it works and how safe it is. The medication helps the immune system control abnormal blood cells to prevent serious health issues. Ropeginterferon alfa-2b is a new form of treatment recently shown to be safe and effective in polycythemia vera.

Research Team

Ole Zagrijtschuk, MD, PhD

Principal Investigator

PharmaEssentia Corporation

Eligibility Criteria

Adults with Polycythemia Vera (PV) can join this trial if they have certain levels of hemoglobin, good liver function, adequate neutrophil counts, and sufficient kidney clearance. Women must not breastfeed and those who can bear children should use birth control during the study.

Inclusion Criteria

I agree to use birth control during and 60 days after the study, and I won't breastfeed if participating.

Written informed consent obtained from the subject or legally authorized representative, and ability for the subject to comply with the requirements of the study

My liver is functioning well according to recent tests.

Treatment Details

Interventions

• P1101 (Ropeginterferon alfa-2b-njft) (Interferon)

Trial Overview The trial is testing P1101 (Ropeginterferon alfa-2b-njft), a medication for PV. It aims to see how well it works, its safety profile, and how tolerable it is for patients when taken as prescribed in the study protocol.

Participant Groups

Group I: P1101 250-350-500mcg Experimental Treatment 1 Intervention

Pre-filled Syringe, Q2W starting at 250-350-500, SC injection

Group II: Ropeginterferon alfa-2b-njft Active Control 1 Intervention

Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection

Who Is Running the Clinical Trial?

PharmaEssentia

Lead Sponsor

Trials

24

Recruited

2,800+