A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

Key facts

Study ID

NCT01331850

Run by

Hoffmann-La Roche

People needed

381

Starts

2011-05-01

Expected to finish

2013-01-01

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…

• Adult patients, age 18 years and older
• Presence of hepatitis C infection, genotype 1a or 1b
• Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
• Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

You may not qualify if…

• Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
• Patients with cirrhosis
• Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
• Co-infection with hepatitis B or human immunodeficiency virus (HIV)
• History or evidence of chronic liver disease other than hepatitis C

Where it is running

• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Orlando, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, 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 — Chapel Hill, 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 — Darlinghurst, New South Wales, Australia
• Study site — Kingswood, New South Wales, Australia
• Study site — Westmead, New South Wales, Australia
• Study site — Adelaide, South Australia, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — Melbourne, Victoria, Australia
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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