Myeloproliferative Neoplasms Clinical Trial

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

Summary

A Phase IIIb, Single-Arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Polycythemia Vera (PV)

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Full Description

Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)

Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.

This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.

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Eligibility Criteria

Inclusion Criteria:

Male or female subjects aged ≥18 years at the time of signing the informed consent form
Subjects diagnosed with PV according to the 2016 World Health Organization (WHO) criteria
With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
Neutrophil count ≥1.5 × 109/L at screening
Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
Males and females of childbearing potential, as well as all women <2 years after the onset of menopause, must agree to use an acceptable form birth control until 60 days following last dose study drug, and females not breastfeed during (see Appendix 4 for details)
Written informed consent obtained from the subject or legally authorized representative, and ability for the subject to comply with the requirements of the study

Exclusion Criteria:

Any contraindications to interferon alfa or hypersensitivity to interferon alfa
Have received previous interferon alfa or ruxolitinib therapy
With severe or serious diseases that the Investigator determines may affect the subject's participation in this study
History of major organ transplantation
Pregnant or breastfeeding women
Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
Use any investigational drug <4 weeks prior to the first dose of study drug, or not recovered from effects administration any investigational drug

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

64

Study ID:

NCT05481151

Recruitment Status:

Active, not recruiting

Sponsor:

PharmaEssentia

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There are 12 Locations for this study

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Tulane University Medical Center
New Orleans Louisiana, 70112, United States
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda Maryland, 20817, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Mount Sinai
New York New York, 10029, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Tennessee Health Science Center
Memphis Tennessee, 38103, United States
MD Anderson
Houston Texas, 77030, United States
University of Utah
Salt Lake City Utah, 84131, United States
University of Virginia - Emily Couric Cancer Center
Charlottesville Virginia, 22903, United States
St. Paul's Hospital
Vancouver British Columbia, , Canada
Juravinski Cancer Centr - Hamilton Health Sciences
Hamilton Ontario, , Canada
The Ottawa Hospital
Ottawa Ontario, , Canada
Princess Margaret Hospital
Toronto Ontario, , Canada

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

64

Study ID:

NCT05481151

Recruitment Status:

Active, not recruiting

Sponsor:


PharmaEssentia

How clear is this clinincal trial information?

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