ECLIPSE PV / A22-203
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug P1101 (Ropeginterferon alfa-2b-njft) for treating polycythemia vera?
Is ropeginterferon alfa-2b safe for humans?
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ropeginterferon alfa-2b-njft (P1101) with dosing regimens of 250-350-500 mcg or 100 up to 500 mcg, administered via subcutaneous injection every two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- P1101 (Ropeginterferon alfa-2b-njft)
Find a Clinic Near You
Who Is Running the Clinical Trial?
PharmaEssentia
Lead Sponsor