A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
1 other identifier
interventional
168
2 countries
25
Brief Summary
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is \<200.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2010
25 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
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedNovember 2, 2016
November 1, 2016
2.2 years
January 26, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)
24 weeks after last treatment dose
Secondary Outcomes (3)
Virologic response over time
weeks 4, 12, 24, 36, 48 and 60
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin
week 12 and 24
Resistance profile of RO5024048
weeks 1-24
Study Arms (2)
Arm A: With RO5024048
EXPERIMENTALPatients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily).
Arm B: Standard treatment
ACTIVE COMPARATORPatients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-70 years of age
- hepatitis C, genotype 1 or 4, of over 6 months duration
- treatment-naïve
- negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
You may not qualify if:
- pregnant or breast feeding females or male partners of pregnant females
- previous interferon or ribavirin based therapy or investigational anti-HCV agent
- systemic antiviral therapy with established or perceived activity against HCV \</=3 months prior to first dose of study drug
- hepatitis A or B, or HIV infection
- history or evidence of medical condition associated with chronic liver disease other than HCV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
Honolulu, Hawaii, 96817, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
Lebanon, New Hampshire, 03756, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
The Bronx, New York, 10468, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78234, United States
Unknown Facility
Calgary, Alberta, T2N 4Z6, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1H2, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 2K5, Canada
Unknown Facility
Winnipeg, Manitoba, R3A 1R9, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
Related Publications (1)
Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.
PMID: 24154738DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
February 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11