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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01194037

Enrollment

Registered

2010-09-02

Start date

2011-06-23

Completion date

2011-11-28

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection, Genotype 1

Keywords

Hepatitis C, HCV, Interferon, Hanferon

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).

Interventions

DRUGrecombinant variant of interferon-alpha 2b

SC, Weekly

DRUGPeginterferon alfa-2a

SC Weekly

DRUGRibavirin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HCV RNA level	Week 4

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026