A Phase 2 interventional study of Copegus and Copegus in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Completed at 24 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-05.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.
Drug: Copegus · Drug: Pegasys · Drug: boceprevir · Drug: mericitabine
24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Drug: Copegus · Drug: Pegasys · Drug: boceprevir · Drug: mericitabine
4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Drug: Copegus · Drug: Pegasys · Drug: mericitabine placebo · Drug: boceprevir placebo · Drug: boceprevir
total daily dose of 1000 mg or 1200 mg for 24 weeks
total daily dose of 1000 mg or 1200 mg for 48 weeks
180 microgram subcutaneous once a week for 24 weeks
180 microgram subcutaneous once a week for 48 weeks
800 mg three times a day for 24 weeks
800 mg three times a day for 48 weeks
1000 mg twice daily for 24 weeks
mericitabine placebo
boceprevir placebo
800 mg three times a day for 44 weeks
Sustained virological response 12 weeks after treatment (SVR-12)
Time frame: up to 60 weeks
Sustained virological response 4 weeks after treatment
Time frame: up to 52 weeks
Virologic response over time
Time frame: 60 weeks
Proportion of patients who develop treatment resistance
Time frame: 60 weeks
Safety (incidence of adverse events)
Time frame: 60 weeks
Pharmacokinetics: trough concentration of RO4995855
Time frame: Day 1 and Week 8
Pharmacokinetics: trough concentration of RO5012433
Time frame: Day 1 and Week 8
Pharmacokinetics: trough concentration of boceprevir
Time frame: Day 1 and Week 8
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche