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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 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.

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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

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

What the Registry Record Tells You About NCT05481151

The ClinicalTrials.gov registry entry for NCT05481151 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 335-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (67% lower). The listed sponsor is PharmaEssentia, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.