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

Status unconfirmed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01001754

Run by

ZymoGenetics

People needed

600

Starts

2010-05-01

Expected to finish

2012-05-01

Last updated by the study team

2011-12-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Coronado, California, United States
• Study site — La Jolla, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lutherville, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Newark, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Arlington, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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