A Phase 2 interventional study of Copegus and Copegus in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 67 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 381 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
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Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria:
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus · Drug: RO5024048 · Drug: danoprevir · Drug: ritonavir
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 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.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048 · Drug: danoprevir · Drug: ritonavir
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 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.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048 · Drug: danoprevir · Drug: ritonavir
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus · Drug: RO5024048 · Drug: danoprevir · Drug: ritonavir
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus · Drug: Pegasys · Drug: danoprevir · Drug: ritonavir
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 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.
Drug: Copegus · Drug: Pegasys · Drug: RO5024048 · Drug: danoprevir · Drug: ritonavir
1000 mg or 1200 mg daily oral doses for 24 weeks
1000 mg or 1200 mg daily oral doses for 48 weeks
180 microgram subcutaneously once weekly for 24 weeks
180 microgram subcutaneously once weekly for 48 weeks
1000 mg oral doses twice a day for 24 weeks
100 mg oral doses twice a day for 24 weeks
100 mg oral doses twice a day for 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Time frame: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment
Time frame: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Time frame: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment
Time frame: 48 weeks
Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus
Time frame: 48 weeks
Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus
Time frame: 48 weeks
Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus
Time frame: 72 weeks
Virological response over time
Time frame: 48 weeks
Change in danoprevir plasma concentration
Time frame: 24 weeks
Change in RO5024048 plasma concentration
Time frame: 24 weeks
Hepatitis C virus drug resistance profile
Time frame: 24 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche