A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4
A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection
2 other identifiers
interventional
413
9 countries
65
Brief Summary
This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.
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 2001
Longer than P75 for phase_2
65 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
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 2, 2016
November 1, 2016
11 years
March 25, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level
24 weeks after end of treatment
Secondary Outcomes (4)
Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
60 Weeks
Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
12 weeks post-treatment
Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment
72 weeks
Safety: Incidence of adverse events
72 weeks
Study Arms (6)
Group 1
EXPERIMENTALRO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Group 2
EXPERIMENTALRO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Group 3
EXPERIMENTALRO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Group 4
EXPERIMENTALGroup 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks
Group 5
ACTIVE COMPARATORGroup 5 will receive SOC for 48 weeks
Group 6
EXPERIMENTALGroup 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients, 18-65 years of age
- Chronic hepatitis C, genotype 1 or 4
- Treatment-naive
You may not qualify if:
- No previous treatment with any interferon- or ribavirin-based therapy
- Other forms of liver disease
- HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92103-8465, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Gainesville, Florida, 32610-0214, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
Newark, New Jersey, 07102, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Providence, Rhode Island, 02905, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Nashville, Tennessee, 37211, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78234, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Sydney, New South Wales, 2050, Australia
Unknown Facility
Greenslopes, Queensland, 4120, Australia
Unknown Facility
Herston, Queensland, 4006, Australia
Unknown Facility
Woolloongabba, Queensland, 4102, Australia
Unknown Facility
Fitzroy, Victoria, 3065, Australia
Unknown Facility
Melbourne, Victoria, 3004, Australia
Unknown Facility
Nedlands, Western Australia, 6009, Australia
Unknown Facility
Perth, Western Australia, 6001, Australia
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Calgary, Alberta, T2N 4Z6, Canada
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 2K5, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Toronto, Ontario, M5G 1L7, Canada
Unknown Facility
Montreal, Quebec, H2X 3J4, Canada
Unknown Facility
Créteil, 94010, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Frankfurt am Main, 60590, Germany
Unknown Facility
Freiburg im Breisgau, 79106, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
München, 81377, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Milan, Lombardy, 20121, Italy
Unknown Facility
Turin, Piedmont, 10126, Italy
Unknown Facility
Pisa, Tuscany, 56124, Italy
Unknown Facility
Santurce, 00909, Puerto Rico
Unknown Facility
Badalona, Barcelona, 08915, Spain
Unknown Facility
Barcelona, Barcelona, 08003, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Granada, Granada, 18003, Spain
Unknown Facility
A Coruña, La Coruña, 15006, Spain
Unknown Facility
Madrid, Madrid, 28222, Spain
Unknown Facility
Seville, Sevilla, 41014, Spain
Unknown Facility
Valencia, Valencia, 46014, Spain
Unknown Facility
London, SE5 9RS, United Kingdom
Unknown Facility
London, W1 1TF, United Kingdom
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
March 25, 2009
First Posted
March 26, 2009
Study Start
February 1, 2001
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11