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ACTIVE NOT RECRUITING
NCT05481151
PHASE3

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

Sponsor: PharmaEssentia

View on ClinicalTrials.gov

Summary

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

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2022-10-26

Completion Date

2027-07-31

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

DRUG

P1101 (Ropeginterferon alfa-2b-njft)

Ropeginterferon alfa-2b-njft

DRUG

Ropeginterferon alfa-2b-njft (P1101)

Ropeginterferon alfa-2b-njft

Locations (23)

Baptist MD Anderson

Jacksonville, Florida, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Mercy Health

Paducah, Kentucky, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)

Bethesda, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Astera HealthCare

East Brunswick, New Jersey, United States

Mount Sinai

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest Baptist Medical Center

High Point, North Carolina, United States

University of Tennessee Health Science Center

Memphis, Tennessee, United States

MD Anderson

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia - Emily Couric Cancer Center

Charlottesville, Virginia, United States

Tom Baker Cancer Centre

Calgary, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Juravinski Cancer Center - Hamilton Health Sciences

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada