Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection

Summary

Primary objectives: The purpose of this study is to determine and compare the sustained virologic response (SVR, undetectable HCV RNA at Follow up week 24 (FW24)) across treatment groups. To determine and compare the safety and tolerability of P1101 + Ribavirin across treatment groups.

Timeline

Start

2011-10-18

Primary completion

2016-11-22

Completion

2016-11-22

Publications

• Results Lin HH, Hsu SJ, Lu SN, Chuang WL, Hsu CW, Chien RN, Yang SS, Su WW, Wu JC, Lee TH, Peng CY, Tseng KC, Qin A, Huang YW, Chen PJ. Ropeginterferon alfa-2b in patients with genotype 1 chronic hepatitis C: Pharmacokinetics, safety, and preliminary efficacy. JGH Open. 2021 Jul 10;5(8):929-940. doi: 10.1002/jgh3.12613. eCollection 2021 Aug.

Drugs

Indications