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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C Infection, Genotype 1

Intervention / Treatment
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* Drug: recombinant variant of interferon-alpha 2b
* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hanferon (low dose) sc weekly + RBV oral daily<br> | Drug: recombinant variant of interferon-alpha 2b<br>* SC, Weekly<br>* Other names: Hanferon;|
| Experimental: Hanferon (high dose) sc weekly + RBV oral daily<br> | Drug: recombinant variant of interferon-alpha 2b<br>* SC, Weekly<br>* Other names: Hanferon;|
| Active Comparator: Pegasys 180 ug sc weekly + RBV oral daily<br> | Drug: Peginterferon alfa-2a<br>* SC Weekly<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA level |  | Week 4 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, HCV, Interferon, Hanferon