CompletedNCT01194037Updated Apr 22, 2025

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

A Phase 1/2 interventional study of recombinant variant of interferon-alpha 2b and Peginterferon alfa-2a in Chronic Hepatitis C Infection and Genotype 1, sponsored by HanAll BioPharma Co., Ltd.. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by HanAll BioPharma Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

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.

Read the 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 studied

Chronic Hepatitis C Infection
Genotype 1

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Keywords

Hepatitis C
HCV
Interferon
Hanferon

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

HanAll BioPharma Co., Ltd. is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

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

Interventions

Drugrecombinant variant of interferon-alpha 2b
SC, Weekly
Also known as: Hanferon
DrugPeginterferon alfa-2a
SC Weekly
Also known as: Pegasys
DrugRibavirin
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)

What researchers measure

Primary outcomes

HCV RNA level
Time frame: Week 4

Secondary outcomes

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

Study locations

6 sites

Los Angeles, California 90036, United States
National City, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01194037
Lead sponsor: HanAll BioPharma Co., Ltd.
Responsible party: Sponsor
First posted: Sep 2, 2010
Start date: Jun 23, 2011
Primary completion: Nov 28, 2011
Completion: Nov 28, 2011
Last update: Apr 22, 2025

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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