A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

Key facts

Study ID

NCT01220947

Run by

Hoffmann-La Roche

People needed

421

Starts

2010-11-01

Expected to finish

2012-12-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults patients, >/=18 years of age
• Chronic Hepatitis C, Genotype 1 and 4
• HCV RNA >/=50,000 IU/mL
• treatment-naive

You may not qualify if…

• Patients with cirrhosis or incomplete/transition to cirrhosis
• Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Where it is running

• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Orlando, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Lutherville, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Fayetteville, North Carolina, United States
• Study site — Medford, Oregon, United States
• Study site — Providence, Rhode Island, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Newport News, Virginia, United States
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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