This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test
Time frame: 12 weeks after end of treatment (up to Week 60)
Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test
Time frame: 4 weeks after end of treatment (up to Week 52)
Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test
Time frame: 24 weeks after end of treatment (up to Week 72)
Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
Time frame: Weeks 2, 4, 12, 24, and 48
Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
Time frame: Baseline up to Week 60
Change From Baseline in HCV Ribonucleic Acid (RNA) Levels
Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Percentage of Participants With Adverse Event
Time frame: Baseline up to Week 72
Trough Concentration of RO4995855 (Parent Drug of Mericitabine)
Time frame: Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
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Participants will receive placebo matching to mericitabine orally twice daily.
Participants will receive telaprevir 750 mg orally three times daily.
Birmingham Gastro Associates, P.C.
Birmingham, Alabama, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Gastroenterology Group of Naples
Naples, Florida, United States
John Hopkins Hospital
Lutherville, Maryland, United States
Metrowest Medical Center
Framingham, Massachusetts, United States
Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
...and 29 more locations
Trough Concentration of Metabolite of RO4995855 (RO5012433)
Time frame: Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Trough Concentration of Telaprevir
Time frame: Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8