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

Phase 1

Completed

• Conditions: Chronic Hepatitis C Infection; Genotype 1
• Interventions: Drug: recombinant variant of interferon-alpha 2b; Drug: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT01194037
• Lead Sponsor: HanAll BioPharma Co., Ltd.

Brief 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).

Study Timeline

• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Study Start: 2011-06-23
• Primary Completion: 2011-11-28
• Study Completion: 2011-11-28
• Status Verified: 2014-02
• Disposition First Submitted: 2025-04-16
• Disposition First Posted: 2025-04-18
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of chronic hepatitis C genotype 1a or 1b
• Male or female aged 18 to 65 years, inclusive
• Compensated liver disease without evidence of cirrhosis
• No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
• No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
• Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia

Exclusion Criteria

• History of previous treatment of hepatitis C
• Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
• History or presence of chronic liver disease
• History of drug or alcohol abuse within the past year
• Evidence of active illicit drug use
• Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
• Female subject who has a positive urine pregnancy test or who is lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily	recombinant variant of interferon-alpha 2b	Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily	Ribavirin	Hanferon™ 30 μg SC weekly + ribavirin(RBV)1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily	recombinant variant of interferon-alpha 2b	Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily	Ribavirin	Hanferon™ 60 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
Pegasys 180 ug sc weekly + RBV oral daily	Peginterferon alfa-2a	Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)
Pegasys 180 ug sc weekly + RBV oral daily	Ribavirin	Pegasys® 180 μg SC weekly + ribavirin(RBV) 1000 mg daily (body weight \< 75kg) or ribavirin(RBV) 1200 mg daily (body weight ≥ 75 kg)

Primary Outcome Measures

Name	Time	Method
HCV RNA level	Week 4

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who reach RVR	Week 4
PK & PD	Weeks 0 and 3