NCT01194037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

June 23, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2011

Completed
Last Updated

April 22, 2025

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

September 1, 2010

Last Update Submit

April 20, 2025

Conditions

Chronic Hepatitis C InfectionGenotype 1

Keywords

Hepatitis CHCVInterferonHanferon

Outcome Measures

Primary Outcomes (1)

  • HCV RNA level

    Week 4

Secondary Outcomes (2)

  • Proportion of patients who reach RVR

    Week 4

  • PK & PD

    Weeks 0 and 3

Study Arms (3)

Hanferon (low dose) sc weekly + ribavirin(RBV) oral daily

EXPERIMENTAL

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 2bDrug: Ribavirin

Hanferon (high dose) sc weekly + ribavirin(RBV) oral daily

EXPERIMENTAL

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 2bDrug: Ribavirin

Pegasys 180 ug sc weekly + RBV oral daily

ACTIVE COMPARATOR

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-2aDrug: Ribavirin

Interventions

recombinant variant of interferon-alpha 2bDRUG

SC, Weekly

Also known as: Hanferon
Hanferon (high dose) sc weekly + ribavirin(RBV) oral dailyHanferon (low dose) sc weekly + ribavirin(RBV) oral daily
Peginterferon alfa-2aDRUG

SC Weekly

Also known as: Pegasys
Pegasys 180 ug sc weekly + RBV oral daily
RibavirinDRUG

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

Hanferon (high dose) sc weekly + ribavirin(RBV) oral dailyHanferon (low dose) sc weekly + ribavirin(RBV) oral dailyPegasys 180 ug sc weekly + RBV oral daily

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

National City, California, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 2, 2010

Study Start

June 23, 2011

Primary Completion

November 28, 2011

Study Completion

November 28, 2011

Last Updated

April 22, 2025

Record last verified: 2014-02

Locations

US(6)