Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis

Official Title
-----------------
An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: alb-interferon alfa 2b
* Drug: alb-interferon alfa 2b
* Drug: alb-interferon alfa 2b
* Drug: alb-interferon alfa 2b
* Drug: peg-interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or older Clinical diagnosis of chronic hepatitis C Infection with HCV genotype 2 or 3 No previous IFNα-based therapy Exclusion Criteria: Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV History or current evidence of decompensated liver disease; other forms of liver disease Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) History of moderate, severe or uncontrolled psychiatric disease History of seizure disorder History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease Clinically significant findings on eye/retinal examination History of immunologically mediated disease Organ transplantation other than cornea or hair transplant History of clinically significant hemoglobinopathy Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Drug or alcohol addiction within the last 6 months and/or positive drug screening tests Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14 days prior to Baseline visit Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit. Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit Have a clinically significant laboratory abnormality Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alb-interferon arm 1<br> | Drug: alb-interferon alfa 2b<br>* 900 mcg every 4 weeks<br>* Other names: ABF656;|
| Experimental: alb-interferon arm 2<br> | Drug: alb-interferon alfa 2b<br>* 1200 mcg every 4 weeks<br>* Other names: ABF656;|
| Experimental: alb-interferon arm 3<br> | Drug: alb-interferon alfa 2b<br>* 1500 mcg every 4 weeks<br>* Other names: ABF656;|
| Experimental: alb-interferon arm 4<br> | Drug: alb-interferon alfa 2b<br>* 1800 mcg every 4 weeks<br>* Other names: ABF656;|
| Active Comparator: peg-interferon<br> | Drug: peg-interferon<br>* Peg-interferon alfa 2a: 180 mcg 1x per wk.<br>* Other names: peg-IFN;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | at every visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load |  | at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis C, genotype 2, genotype 3, albumin interferon alfa-2b, alb-interferon