A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | May 2011 |
| End Date: | January 2013 |
A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
19
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