Overview

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

Status:
Completed
Trial end date:
2020-07-15
Target enrollment:
Participant gender:
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
Phase:
Phase 3
Details
Lead Sponsor:
PharmaEssentia
Collaborator:
Clinipace Worldwide
Treatments:
Peginterferon alfa-2b
Ribavirin