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

• Status: Not yet recruiting
• Trial end date: 2025-12-28
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaEssentia

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 2016 World Health Organization (WHO) criteria

3. 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 × 109/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 (see Appendix 4 for details)

8. 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:

1. Any contraindications to interferon alfa or hypersensitivity to interferon alfa

2. Have received previous interferon alfa or ruxolitinib therapy

3. 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:

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