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Last Updated: May 31, 2020

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CLINICAL TRIALS PROFILE FOR DANOPREVIR


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Clinical Trials for Danoprevir

Trial ID Title Status Sponsor Phase Summary
NCT00801255 A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients Completed Hoffmann-La Roche Phase 1 This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
NCT00963885 A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection Completed Hoffmann-La Roche Phase 2 This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
NCT01164488 A Study of RO5190591 (Danoprevir) in Healthy Volunteers Completed Hoffmann-La Roche Phase 1 This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Danoprevir

Condition Name

Condition Name for
Intervention Trials
Healthy Volunteer 15
Hepatitis C, Chronic 9
Healthy 3
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Condition MeSH

Condition MeSH for
Intervention Trials
Hepatitis C, Chronic 12
Hepatitis C 12
Hepatitis 12
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Clinical Trial Locations for Danoprevir

Trials by Country

Trials by Country for
Location Trials
United States 79
Canada 13
Italy 9
Australia 9
France 7
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Trials by US State

Trials by US State for
Location Trials
Kansas 10
California 6
Texas 5
New York 5
Michigan 5
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Clinical Trial Progress for Danoprevir

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 24
Active, not recruiting 5
Recruiting 3
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Clinical Trial Sponsors for Danoprevir

Sponsor Name

Sponsor Name for
Sponsor Trials
Hoffmann-La Roche 24
Ascletis Pharmaceuticals Co., Ltd. 9
Huoshenshan Hospital 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 33
Other 2
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