Hepatitis C, Chronic
Conditions
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.
Interventions
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, 18-65 years of age * Chronic hepatitis C, genotype 1 or 4 * Treatment-naive
Exclusion criteria
* No previous treatment with any interferon- or ribavirin-based therapy * Other forms of liver disease * HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level | 24 weeks after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Virologic response: Percentage of patients with undetectable Hepatitis C RNA level | 60 Weeks |
| 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 |
Countries
Australia, Austria, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
Outcome results
None listed