Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: HCV Infection

In brief

The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care \[SOC\]) compared to placebo + SOC.

Key facts

Study ID

NCT00978497

Run by

Hoffmann-La Roche

People needed

97

Starts

2009-09-01

Expected to finish

2011-08-01

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, ages 18 to 65 years
• Documented chronic HCV infection, genotype 1a or 1b
• Treatment-naïve

You may not qualify if…

• Female patients who are pregnant or breast-feeding
• Infection with non-genotype 1 HCV
• Previous treatment for HCV infection
• HIV or HBV positive
• Any medical contraindication to Peg-IFN or RBV therapy
• History of any other known cause of liver disease

Where it is running

• United States, California 1 — Anaheim, California, United States
• United States, California 4 — Los Angeles, California, United States
• United States, California 2 — San Clemente, California, United States
• United States, California 3 — San Diego, California, United States
• United States, California 5 — San Francisco, California, United States
• United States, Florida 2 — Gainesville, Florida, United States
• United States, Florida 3 — Miami, Florida, United States
• United States, Florida 1 — Sarasota, Florida, United States
• United States, Maryland — Lutherville, Maryland, United States
• United States, Massachusetts — Boston, Massachusetts, United States
• United States, Michigan — Detroit, Michigan, United States
• United States, New York — New York, New York, United States
• United States, North Carolina — Chapel Hill, North Carolina, United States
• United States, North Carolina — Durham, North Carolina, United States
• United States, Ohio — Cincinnati, Ohio, United States
• United States, Pennsylvania — Philadelphia, Pennsylvania, United States
• United States, Texas 2 — Houston, Texas, United States
• United States, Texas 1 — San Antonio, Texas, United States
• United States, Virginia 1 — Fairfax, Virginia, United States
• United States, Virginia 2 — Falls Church, Virginia, United States
• Puerto Rico — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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