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

April 20, 2025 updated by: HanAll BioPharma Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
SC, Weekly
Other Names:
  • Hanferon
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)
Other Names:
  • antiviral medication
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
SC, Weekly
Other Names:
  • Hanferon
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)
Other Names:
  • antiviral medication
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
SC Weekly
Other Names:
  • Pegasys
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)
Other Names:
  • antiviral medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HCV RNA level
Time Frame: Week 4
Week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2011

Primary Completion (Actual)

November 28, 2011

Study Completion (Actual)

November 28, 2011

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimated)

September 2, 2010

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-143IFN-SC-US-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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