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

NCT04382937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2022-01-18

No results posted yet for this study

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

Conditions

  • Chronic Hepatitis C Virus Infection

Interventions

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

Sponsors & Collaborators

  • PharmaEssentia

    lead INDUSTRY

Principal Investigators

  • Yi-Wen Huang, MD/PhD · PharmaEssentia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2020-07-15
Completion
2020-07-15

Countries

  • China
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382937 on ClinicalTrials.gov