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A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

NCT01194037 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-22

No results posted yet for this study

Summary

This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.

Conditions

  • Chronic Hepatitis C Infection
  • Genotype 1

Interventions

DRUG

recombinant variant of interferon-alpha 2b

SC, Weekly

DRUG

Peginterferon alfa-2a

SC Weekly

DRUG

Ribavirin

Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)

Sponsors & Collaborators

  • HanAll BioPharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-23
Primary Completion
2011-11-28
Completion
2011-11-28

Countries

  • United States

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 NCT01194037 on ClinicalTrials.gov