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Randomized, Open-Label, Multicenter Study of Safety, Efficacy, and Tolerability of the Combination of RO5466731, RO5190591, Ritonavir, and Copegus With or Without RO5024048 in HCV Genotype 1 Infected Patients Who Are Either Treatment Naïve or Null Responders to Previous Interferon-Based Treatment
This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
La Jolla, California, United States
Englewood, Colorado, United States
South Miami, Florida, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Detroit, Michigan, United States
Saint Louise, Missouri, United States
Asheville, North Carolina, United States
Start Date
June 1, 2012
Primary Completion Date
November 1, 2013
Completion Date
November 1, 2013
Last Updated
November 2, 2016
110
ACTUAL participants
RO5024048
DRUG
RO5190591
DRUG
RO5466731
DRUG
ribavirin [Copegus]
DRUG
ritonavir
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05870969
NCT03987503
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04382404