Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00801255 |
This 4 cohort study will evaluate the efficacy and safety of combination treatment with an HCV polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591) in patients with chronic hepatitis C, genotype 1. Cohorts A and B are designed to evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. if supported by safety data from the first 2 cohorts, cohorts C and D are designed to evaluate combination treatment with up to 1000mg po bid RO5024048 and up to 200mg q8h RO5190591 for 14 days. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Chronic |
Drug: RO5024048/RO5190591 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. |
Estimated Enrollment: | 64 |
Estimated Study Completion Date: | November 2009 |
Arms | Assigned Interventions |
---|---|
Cohort A: Experimental |
Drug: RO5024048/RO5190591
500mg po bid/100mg po q8h for 7 days
|
Cohort B: Experimental |
Drug: RO5024048/RO5190591
500mg po bid/100mg po q8h for 14 days
|
Cohort C: Experimental |
Drug: RO5024048/RO5190591
1000mg po bid/100mg po q8h for 14 days 500mg po bid/200mg po q8h for 14 days
|
Cohort D: Experimental |
Drug: RO5024048/RO5190591
1000mg po bid/200mg po q8h for 14 days
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: PP22205 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Australia | |
Recruiting | |
MELBOURNE, Australia, 3181 | |
Recruiting | |
HEIDELBERG, Australia, 3084 | |
Recruiting | |
ADELAIDE, Australia, SA 5000 | |
New Zealand | |
Recruiting | |
AUCKLAND, New Zealand, 1150 | |
Recruiting | |
CHRISTCHURCH, New Zealand |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | PP22205 |
Study First Received: | December 2, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00801255 |
Health Authority: | New Zealand: Health Research Council |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Flaviviridae Infections |