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Interferon

ECLIPSE PV / A22-203

Phase 3
Recruiting
Research Sponsored by PharmaEssentia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
Timeline
Screening 28 days
Treatment 48 weeks
Follow Up 28 days
Awards & highlights

Study Summary

This triallooks at how a drug affects people with a blood disorder called polycythemia vera, to assess safety and effectiveness.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with interferons like P1101 may include flu-like symptoms, tiredness, mood changes, nausea, and injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is functioning well according to recent tests.
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My hemoglobin level is at least 10 g/dL if I am female, or 11 g/dL if I am male.
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My kidneys are functioning well enough (creatinine clearance rate ≥40 mL/min).
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I agree to use birth control during and 60 days after the study, and I won't breastfeed if participating.

Timeline

Screening ~ 28 days
Treatment ~ 48 weeks
Follow Up ~28 days
This trial's timeline: 28 days for screening, 48 weeks for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: P1101 250-350-500mcgExperimental Treatment1 Intervention
Pre-filled Syringe, Q2W starting at 250-350-500, SC injection
Group II: Ropeginterferon alfa-2b-njftActive Control1 Intervention
Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

PharmaEssentiaLead Sponsor
20 Previous Clinical Trials
1,320 Total Patients Enrolled
2 Trials studying Polycythemia Vera
159 Patients Enrolled for Polycythemia Vera
Ray Urbanski, MD, PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
64 Total Patients Enrolled
Ray Urbanski, MD/PhDStudy DirectorPharmaEssentia USA Corporation
1 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

P1101 (Ropeginterferon alfa-2b-njft) (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT05481151 — Phase 3
Polycythemia Vera Research Study Groups: P1101 250-350-500mcg, Ropeginterferon alfa-2b-njft
Polycythemia Vera Clinical Trial 2023: P1101 (Ropeginterferon alfa-2b-njft) Highlights & Side Effects. Trial Name: NCT05481151 — Phase 3
P1101 (Ropeginterferon alfa-2b-njft) (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05481151 — Phase 3
Polycythemia Vera Patient Testimony for trial: Trial Name: NCT05481151 — Phase 3
~39 spots leftby May 2025
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