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

Phase 3

• Conditions: Chronic Hepatits C; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12607000092493
• Lead Sponsor: Human Genome Sciences, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified