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NCT05481151 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
A Phase 3 study of Polycythemia Vera, sponsored by PharmaEssentia.
- Active
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
- 20
- Study locations
NCT05481151: Active Phase 3 study of Polycythemia Vera, sponsored by PharmaEssentia.
NCT05481151 is a Phase 3 study of Polycythemia Vera that is active but no longer recruiting, run by PharmaEssentia. The registered enrollment target is 111 participants, below the 335-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05481151, a Phase 3 study of Polycythemia Vera, is active but no longer recruiting, sponsored by PharmaEssentia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Primary Outcome
CHR is defined as hematocrit (HCT) \<45%, white blood cell (WBC) count \<10 × 10\^9/L, platelets (PLT) ≤400 × 10\^9/L in the absence of phlebotomy in the previous 12 weeks.
Conditions Studied
Interventions
- DRUG Ropeginterferon alfa-2b-njft (P1101)
- DRUG P1101 (Ropeginterferon alfa-2b-njft)
Study Locations (20)
North Carolina
- University of North Carolina Lineberger Comprehensive Cancer Center - Chapel Hill
- East Carolina University - Greenville
- Wake Forest Baptist Medical Center - High Point
New York
- Mount Sinai - New York
- Montefiore Medical Center - The Bronx
Florida
- Baptist MD Anderson - Jacksonville
Indiana
- Fort Wayne Medical Oncology and Hematology - Fort Wayne
Kansas
- University of Kansas Medical Center - Westwood
Kentucky
- Mercy Health - Paducah
Louisiana
- Tulane University Medical Center - New Orleans
Maryland
- American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 3 |
What the registry record for NCT05481151 still lists
NCT05481151 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 335-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Polycythemia Vera appearing as the primary indexed condition, and to 2 interventions - of which Ropeginterferon alfa-2b-njft (P1101) is the first listed.
NCT05481151 names 20 study sites across 17 states, led by North Carolina, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT05481151 about?
NCT05481151 is a clinical study titled "A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV". A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
What is the current status of trial NCT05481151?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2022-10-26. Estimated completion is 2027-07-31.
What conditions does trial NCT05481151 study?
This clinical trial studies the following conditions: Polycythemia Vera.
What interventions are being tested in trial NCT05481151?
The interventions under investigation include: Ropeginterferon alfa-2b-njft (P1101) (DRUG), P1101 (Ropeginterferon alfa-2b-njft) (DRUG).
Who is sponsoring clinical trial NCT05481151?
This trial is sponsored by PharmaEssentia, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05481151 being conducted?
This trial has 20 study locations across Florida, Indiana, Kansas, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Polycythemia Vera
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05481151's enrollment target sits among peer trials
111 7th of 22 higher than 16 of 22 other Polycythemia Vera trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Polycythemia Vera trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
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