None listed
Conditions
Brief summary
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.
Interventions
Subcutaneous injections of albumin interferon alfa-2b 900mcg or 1200mcg every 2 weeks and oral administration of ribavirin 800mg daily. Duration: 24 week treatment.
Sponsors
Human Genome Sciences, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed