ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
NCT ID: NCT01628094
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2012-06-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: GT1a 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048
RO5024048
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
B: GT1a 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048
RO5024048
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
C: GT1a 2DAA
including RO5466731, RO5190591, ritonavir and ribavirin \[Copegus\]
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
D: GT1b 3DAA
including RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048
RO5024048
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
E: GT1b 2DAA
including RO54664731, RO5190591, ritonavir and ribavirin \[Copegus\]
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
Part II
RO5024048
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
Interventions
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RO5024048
RO5190591
RO5466731
ribavirin [Copegus]
ritonavir
Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis C genotype 1 of \>/= 6 months duration at screening
* Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
* Part 2: Treatment experienced patients having a previous null response to treatment with interferon containing regimen
* Liver biopsy or non-invasive (e.g. Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
* Body mass index (BMI) 18 to 35 kg/m2 inclusive and body weight \>/= 45 kg
Exclusion Criteria
* Decompensated liver disease or impaired liver function (as defined by protocol)
* Cirrhosis or incomplete/transition to cirrhosis
* Non- hepatitis C chronic liver disease
* Positive for hepatitis B or HIV infection
* History of pre-existing renal disease
* History of severe cardiac disease
* History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
* History of drug abuse within the last year; history of cannabinoid use is not excluded
* Evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
* Medical condition that requires use of systemic corticosteroids
* Received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
* Anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Vancouver, Washington, United States
Kingswood, New South Wales, Australia
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
Herston, Queensland, Australia
Parkville, Victoria, Australia
Berlin, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Dunedin, , New Zealand
Grafton, , New Zealand
Hamilton, , New Zealand
Bialystok, , Poland
Chorzów, , Poland
Lodz, , Poland
Mysłowice, , Poland
Countries
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References
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Jensen DM, Brunda M, Elston R, Gane EJ, George J, Glavini K, Hammond JM, Le Pogam S, Najera I, Passe S, Piekarska A, Rodriguez I, Zeuzem S, Chu T; ANNAPURNA study investigators. Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study. Liver Int. 2016 Apr;36(4):505-14. doi: 10.1111/liv.12997. Epub 2015 Dec 12.
Other Identifiers
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2012-000638-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP28266
Identifier Type: -
Identifier Source: org_study_id