NCT04382937

Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection

An Open-label, Randomized, Active Control Study to Demonstrate Non-Inferiority in Efficacy, and to Compare Safety and Tolerability of P1101 + Ribavirin to PEG-Intron + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic HCV Genotype 2 Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection

Detailed description

Secondary objective: To determine and compare the efficacy, safety, tolerability and immunogenicity of PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily

Conditions

• Chronic Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	P1101 + Ribavirin	P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
DRUG	PEG-Intron + Ribavirin	PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily

Timeline

• Start date: 2016-01-12
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2020-05-11
• Last updated: 2022-01-18

Locations

39 sites across 3 countries: China, South Korea, Taiwan