A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
1 other identifier
interventional
107
2 countries
18
Brief Summary
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
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 Sep 2006
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 15, 2006
CompletedFirst Posted
Study publicly available on registry
September 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedNovember 2, 2016
November 1, 2016
1.9 years
September 15, 2006
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs) and laboratory parameters.
Week 4, 8 and Week 72
Secondary Outcomes (2)
Plasma concentration of HCV polymerase inhibitor
Week 4 and 8
Antiviral activity
Week 4, 8 and Week 72
Study Arms (4)
PEGASYS with COPEGUS
ACTIVE COMPARATORRO5024048 1500mg in combination with PEGASYS
EXPERIMENTALRO5024048 3000mg in combination with PEGASYS
EXPERIMENTALRO5024048 in combination with PEGASYS and COPEGUS
EXPERIMENTALInterventions
1000/1200mg po daily for 4 weeks
180 micrograms sc weekly for 4 weeks
1500mg po bid for 4 weeks
Eligibility Criteria
You may qualify if:
- adult patients, 18-65 years of age;
- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- chronic liver disease consistent with CHC.
You may not qualify if:
- infection with any HCV genotype other than genotype 1;
- previous treatment for CHC;
- medical condition associated with chronic liver disease other than CHC;
- HIV, Hepatitis A, Hepatitis B infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92103-8465, United States
Unknown Facility
San Diego, California, 92154, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Gainesville, Florida, 32610-0214, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Novi, Michigan, 48377, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Chapel Hill, North Carolina, 27599-7584, United States
Unknown Facility
Dallas, Texas, 75203, United States
Unknown Facility
Fort Sam Houston, Texas, 78234-3879, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Santurce, 00909, Puerto Rico
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
September 15, 2006
First Posted
September 18, 2006
Study Start
September 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
November 2, 2016
Record last verified: 2016-11