A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
Public ClinicalTrials.gov record NCT05481151. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)
Study identification
- NCT ID
- NCT05481151
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- PharmaEssentia
- Industry
- Enrollment
- 111 participants
Conditions and interventions
Conditions
Interventions
- P1101 (Ropeginterferon alfa-2b-njft) Drug
- Ropeginterferon alfa-2b-njft (P1101) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 25, 2022
- Primary completion
- Jun 29, 2025
- Completion
- Jul 30, 2027
- Last update posted
- Aug 12, 2025
2022 – 2027
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baptist MD Anderson | Jacksonville | Florida | 32207 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46804 | — |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | — |
| Mercy Health | Paducah | Kentucky | 42003 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders) | Bethesda | Maryland | 20817 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Astera HealthCare | East Brunswick | New Jersey | 08816 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest Baptist Medical Center | High Point | North Carolina | 27265 | — |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103 | — |
| MD Anderson | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 841312 | — |
| University of Virginia - Emily Couric Cancer Center | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05481151, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2025 · Synced May 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05481151 live on ClinicalTrials.gov.