Back to resultsA 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.
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Copegus
PEGASYS
RO5024048 1500mg
RO5024048 3000mg
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
PEGASYS with COPEGUS
RO5024048 1500mg in combination with PEGASYS
RO5024048 3000mg in combination with PEGASYS
RO5024048 in combination with PEGASYS and COPEGUS
Arm Description
Outcomes
Primary Outcome Measures
Adverse events (AEs) and laboratory parameters.
Secondary Outcome Measures
Plasma concentration of HCV polymerase inhibitor
Antiviral activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00377182
Brief Title
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.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEGASYS with COPEGUS
Arm Type
Active Comparator
Arm Title
RO5024048 1500mg in combination with PEGASYS
Arm Type
Experimental
Arm Title
RO5024048 3000mg in combination with PEGASYS
Arm Type
Experimental
Arm Title
RO5024048 in combination with PEGASYS and COPEGUS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Copegus
Intervention Description
1000/1200mg po daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
PEGASYS
Intervention Description
180 micrograms sc weekly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
RO5024048 1500mg
Intervention Description
1500mg po bid for 4 weeks
Intervention Type
Drug
Intervention Name(s)
RO5024048 3000mg
Intervention Description
3000mg po bid for 4 weeks
Primary Outcome Measure Information:
Title
Adverse events (AEs) and laboratory parameters.
Time Frame
Week 4, 8 and Week 72
Secondary Outcome Measure Information:
Title
Plasma concentration of HCV polymerase inhibitor
Time Frame
Week 4 and 8
Title
Antiviral activity
Time Frame
Week 4, 8 and Week 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1030
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8465
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0214
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7584
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-3879
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
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.
We'll reach out to this number within 24 hrs