NCT01194037

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

A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: HanAll BioPharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).

Conditions

• Chronic Hepatitis C Infection
• Genotype 1

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-06-23
• Primary completion: 2011-11-28
• Completion: 2011-11-28
• First posted: 2010-09-02
• Last updated: 2025-04-22

Locations

6 sites across 1 country: United States