Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection

• Status: Unknown status
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZymoGenetics
• Collaborator: Bristol-Myers Squibb
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor

• HCV genotype 1, 2, 3, or 4

• HCV RNA ≥100,000 IU/mL

• ALT and AST ≤5.0 × ULN

• Documented absence of cirrhosis

• Able to comprehend the investigational nature of this study and sign an informed consent form

Exclusion Criteria:

• Mixed genotype HCV infection

• Current or prior history of decompensated liver disease

• Received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug

• Positive test for hepatitis B surface antigen, human immunodeficiency virus (HIV)-1, or HIV2 antibody at screening

• Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months

Additional inclusion and exclusion criteria are specified in the protocol.