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A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

Primary Purpose

Chronic Hepatitis C Infection, Genotype 1

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant variant of interferon-alpha 2b
Peginterferon alfa-2a
Sponsored by
HanAll BioPharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Hepatitis C, HCV, Interferon, Hanferon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Hanferon (low dose) sc weekly + RBV oral daily

Hanferon (high dose) sc weekly + RBV oral daily

Pegasys 180 ug sc weekly + RBV oral daily

Arm Description

Outcomes

Primary Outcome Measures

HCV RNA level

Secondary Outcome Measures

Proportion of patients who reach RVR
PK & PD

Full Information

First Posted
September 1, 2010
Last Updated
February 24, 2014
Sponsor
HanAll BioPharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01194037
Brief Title
A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
Official Title
A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, Pharmacokinetic/Pharmacodynamic, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HanAll BioPharma Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection, Genotype 1
Keywords
Hepatitis C, HCV, Interferon, Hanferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hanferon (low dose) sc weekly + RBV oral daily
Arm Type
Experimental
Arm Title
Hanferon (high dose) sc weekly + RBV oral daily
Arm Type
Experimental
Arm Title
Pegasys 180 ug sc weekly + RBV oral daily
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
recombinant variant of interferon-alpha 2b
Other Intervention Name(s)
Hanferon
Intervention Description
SC, Weekly
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
SC Weekly
Primary Outcome Measure Information:
Title
HCV RNA level
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Proportion of patients who reach RVR
Time Frame
Week 4
Title
PK & PD
Time Frame
Weeks 0 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
National City
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

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