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ACTIVE NOT RECRUITING Phase 3

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

NCT05481151 · View on ClinicalTrials.gov ↗

Study Summary

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV

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

FieldValue
Enrollment Target 111 participants
Start Date 2022-10-26
Est. Completion 2027-07-31
Phase Phase 3

Sponsor

PharmaEssentia

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05481151

The ClinicalTrials.gov registry entry for NCT05481151 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmaEssentia, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05481151 reports 20 study locations spanning 17 distinct geographic areas — top geographies include North Carolina, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05481151?

This trial is sponsored by PharmaEssentia, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial