Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

Study Overview
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Brief Summary
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This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

Official Title
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Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: albumin interferon alfa-2b
* Drug: peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of chronic hepatitis C. Liver biopsy performed within 2 years of Day 0 or during screening. Infected with hepatitis C virus genotype 2/3. Interferon alfa treatment naïve (ie, have never been treated with an interferon product). Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin. Have compensated liver disease. Key Exclusion Criteria: Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy. History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt. Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG). Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency. A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus). Active seizure disorder within the last 2 years. Organ transplant other than cornea and hair transplant. Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia). Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix). Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study. Received any experimental agent within 28 days prior to Day 0.

Ages Eligible for Study
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Minimum Age: 18 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: 1<br>900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day | Drug: albumin interferon alfa-2b<br>* 900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks<br>Drug: Ribavirin<br>* 800mg/day for 24 weeks<br>|
| Experimental: 2<br>1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day | Drug: albumin interferon alfa-2b<br>* 900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks<br>Drug: Ribavirin<br>* 800mg/day for 24 weeks<br>|
| Active Comparator: 3<br>180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day | Drug: peginterferon alfa-2a<br>* 180 micrograms Pegasys given subcutaneaously once a week for 24 weeks<br>Drug: Ribavirin<br>* 800mg/day for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response (SVR) |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid virologic response |  | Week 4 | 
| Early virologic response |  | Week 12 | 
| Undetectable HCV RNA |  | Week 24 | 
| Normalization of ALT (a liver enzyme) |  | Week 48 | 
| Quality of life evaluation |  | Week 48 | 
| Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results) |  | Througout the entire treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Hepatitis C, CHC, HepC, Genotype 1, Hepatitis, HCV