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
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
2 other identifiers
interventional
110
5 countries
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2012
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 2, 2016
November 1, 2016
1.4 years
June 22, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment
approximately 20 months
Safety: Incidence of adverse events
approximately 20 months
Secondary Outcomes (4)
Antiviral activity: Change in serum HCV RNA levels
from baseline to 24 weeks after end of treatment
Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC)
Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6
HCV drug resistance
approximately 20 months
Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires
approximately 20 months
Study Arms (6)
A: GT1a 3DAA
EXPERIMENTALincluding RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048
B: GT1a 3DAA
EXPERIMENTALincluding RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048
C: GT1a 2DAA
EXPERIMENTALincluding RO5466731, RO5190591, ritonavir and ribavirin \[Copegus\]
D: GT1b 3DAA
EXPERIMENTALincluding RO5466731, RO5190591, ritonavir, ribavirin \[Copegus\] and RO5024048
E: GT1b 2DAA
EXPERIMENTALincluding RO54664731, RO5190591, ritonavir and ribavirin \[Copegus\]
Part II
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/= 18 years of age
- 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
You may not qualify if:
- Pregnant or lactating women or males with female partners who are pregnant or lactating
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Englewood, Colorado, 80113, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Saint Louise, Missouri, 63104, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
San Antonio, Texas, 78234, United States
Unknown Facility
Vancouver, Washington, 98664, United States
Unknown Facility
Kingswood, New South Wales, Australia
Unknown Facility
Sydney, New South Wales, 2050, Australia
Unknown Facility
Westmead, New South Wales, 2145, Australia
Unknown Facility
Herston, Queensland, 4029, Australia
Unknown Facility
Parkville, Victoria, 3052, Australia
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Frankfurt am Main, 60590, Germany
Unknown Facility
Hamburg, 20099, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Dunedin, 9016, New Zealand
Unknown Facility
Grafton, 1010, New Zealand
Unknown Facility
Hamilton, New Zealand
Unknown Facility
Bialystok, 15-540, Poland
Unknown Facility
Chorzów, 41-500, Poland
Unknown Facility
Lodz, 91-357, Poland
Unknown Facility
Mysłowice, 41-400, Poland
Related Publications (1)
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.
PMID: 26519669DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2012
First Posted
June 26, 2012
Study Start
June 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11