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

NCT ID: NCT05481151

Condition: Polycythemia Vera

Conditions: Official terms:
Polycythemia Vera
Polycythemia

Conditions: Keywords:
Polycythemia Vera
Essential Thrombocythemia
P1101
Ropeginterferonalfa-2b-njft
Polycythemia
Vera
PharmaEssentia
Besremi
Ropeg

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: P1101 (Ropeginterferon alfa-2b-njft)
Description: Ropeginterferon alfa-2b-njft
Arm group label: P1101 250-350-500mcg

Intervention type: Drug
Intervention name: Ropeginterferon alfa-2b-njft (P1101)
Description: Ropeginterferon alfa-2b-njft
Arm group label: Ropeginterferon alfa-2b-njft

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

Detailed 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Male or female subjects aged ≥18 years at the time of signing the informed consent form 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: 1. Any contraindications to interferon alfa or hypersensitivity to interferon alfa 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Baptist MD Anderson

Address:
City: Jacksonville
Zip: 32207
Country: United States

Facility:
Name: Fort Wayne Medical Oncology and Hematology

Address:
City: Fort Wayne
Zip: 46804
Country: United States

Facility:
Name: University of Kansas Medical Center

Address:
City: Westwood
Zip: 66205
Country: United States

Facility:
Name: Mercy Health

Address:
City: Paducah
Zip: 42003
Country: United States

Facility:
Name: Tulane University Medical Center

Address:
City: New Orleans
Zip: 70112
Country: United States

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

Address:
City: Bethesda
Zip: 20817
Country: United States

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: Astera HealthCare

Address:
City: East Brunswick
Zip: 08816
Country: United States

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10467
Country: United States

Facility:
Name: Mount Sinai

Address:
City: New York
Zip: 10029
Country: United States

Facility:
Name: University of North Carolina Lineberger Comprehensive Cancer Center

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Facility:
Name: East Carolina University

Address:
City: Greenville
Zip: 27834
Country: United States

Facility:
Name: Wake Forest Baptist Medical Center

Address:
City: High Point
Zip: 27265
Country: United States

Facility:
Name: University of Tennessee Health Science Center

Address:
City: Memphis
Zip: 38103
Country: United States

Facility:
Name: MD Anderson

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: University of Utah

Address:
City: Salt Lake City
Zip: 841312
Country: United States

Facility:
Name: University of Virginia - Emily Couric Cancer Center

Address:
City: Charlottesville
Zip: 22903
Country: United States

Facility:
Name: Tom Baker Cancer Centre

Address:
City: Calgary
Country: Canada

Facility:
Name: St. Paul's Hospital

Address:
City: Vancouver
Country: Canada

Facility:
Name: Juravinski Cancer Center - Hamilton Health Sciences

Address:
City: Hamilton
Country: Canada

Facility:
Name: The Ottawa Hospital

Address:
City: Ottawa
Zip: K1H 8L6
Country: Canada

Facility:
Name: St. Michael's Hospital

Address:
City: Toronto
Zip: M5B 1W8
Country: Canada

Facility:
Name: Princess Margaret Hospital

Address:
City: Toronto
Country: Canada

Start date: October 26, 2022

Completion date: July 31, 2025

Lead sponsor:
Agency: PharmaEssentia
Agency class: Industry

Source: PharmaEssentia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05481151

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