A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
NCT ID: NCT05481151
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
111 participants
INTERVENTIONAL
2022-10-26
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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P1101 250-350-500mcg
Pre-filled Syringe, Q2W starting at 250-350-500, SC injection
P1101 (Ropeginterferon alfa-2b-njft)
Ropeginterferon alfa-2b-njft
Ropeginterferon alfa-2b-njft
Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection
Ropeginterferon alfa-2b-njft (P1101)
Ropeginterferon alfa-2b-njft
Interventions
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P1101 (Ropeginterferon alfa-2b-njft)
Ropeginterferon alfa-2b-njft
Ropeginterferon alfa-2b-njft (P1101)
Ropeginterferon alfa-2b-njft
Eligibility Criteria
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Inclusion Criteria
2. Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
3. Subjects 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
4. Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
5. Neutrophil count ≥1.5 × 10\^9/L at screening
6. Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
7. 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 of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study
8. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study
Exclusion Criteria
2. Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
3. Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
4. History of major organ transplantation
5. Pregnant or breastfeeding women
6. 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:
1. Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
2. Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia \[ITP\], scleroderma, psoriasis, or any autoimmune arthritis)
3. Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia, or a past history of interstitial pneumonia at screening
4. Active infection with systemic manifestations (e.g., presence of bacteria, fungi, and/or human immunodeficiency virus \[HIV\] at screening, excluding hepatitis B \[HBV\] and/or hepatitis C \[HCV\] at screening)
5. Evidence of severe retinopathy (e.g., cytomegalovirus \[CMV\]-induced retinitis, macular degeneration) or clinically significant eye diseases (due to diabetes or hypertension)
6. History or presence of clinically relevant depression per Investigator's judgment
7. Previously had suicidal attempts or has any risk for suicidal tendency at screening
8. Poorly controlled diabetes defined as HbA1c \>8.0% for at least 1 year
9. Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase
10. History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostate-specific antigen (PSA), curative treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study)
11. History of alcohol or drug abuse in the past year
12. History or evidence of post-polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN
13. Presence of blast cells in the peripheral blood in the past 12 weeks
7. Use any investigational drug \<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug
8. Any subject requiring a legally authorized representative
18 Years
ALL
No
Sponsors
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PharmaEssentia
INDUSTRY
Responsible Party
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Principal Investigators
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Ole Zagrijtschuk, MD, PhD
Role: STUDY_DIRECTOR
PharmaEssentia Corporation
Locations
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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
Countries
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Other Identifiers
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ECLIPSE PV / A22-203
Identifier Type: -
Identifier Source: org_study_id
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