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

Chronic Hepatitis C Virus Infection Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04382937
Study type Interventional
Source PharmaEssentia
Contact
Status Completed
Phase Phase 3
Start date January 12, 2016
Completion date July 15, 2020
View Details
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