Hepatitis C
Conditions
Brief summary
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.
Interventions
DRUGRibavirin
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.
DRUGMericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
DRUGPeginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
DRUGPlacebo
Participants will receive placebo matching to mericitabine orally twice daily.
DRUGTelaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis C infection for at least 6 months duration * Hepatitis C genotype 1a or 1b * Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study * Participants showed a previous null response to therapy as defined by \< 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV
Exclusion criteria
* Hepatitis C infection with a genotype other than genotype 1a or 1b * Body mass index \< 18 or \>= 36 kilograms per square meters (kg/m\^2) * Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection * Herbal remedies \<=1 month prior to the first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 12 weeks after end of treatment (up to Week 60) |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | Weeks 2, 4, 12, 24, and 48 |
| Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology | Baseline up to Week 60 |
| Change From Baseline in HCV Ribonucleic Acid (RNA) Levels | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72 |
| 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 | 4 weeks after end of treatment (up to Week 52) |
| Trough Concentration of RO4995855 (Parent Drug of Mericitabine) | 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 Metabolite of RO4995855 (RO5012433) | 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 | 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 |
| Percentage of Participants With Adverse Event | Baseline up to Week 72 |
Countries
Canada, France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed