A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 8/3/2016 |
| Start Date: | February 2010 |
| End Date: | April 2012 |
A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and
antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus
Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients
in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to
Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients
achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop
all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus
for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with
Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.
Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.
antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus
Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients
in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to
Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients
achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop
all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus
for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with
Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.
Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.
Inclusion Criteria:
- adult patients, 18-70 years of age
- hepatitis C, genotype 1 or 4, of over 6 months duration
- treatment-naïve
- negative pregnancy test; female patients of childbearing age and male patients with
female partners of childbearing age must use two forms of contraception during
treatment and following the last dose of ribavirin in accordance with locally
approved label for ribavirin
Exclusion Criteria:
- pregnant or breast feeding females or male partners of pregnant females
- previous interferon or ribavirin based therapy or investigational anti-HCV agent
- systemic antiviral therapy with established or perceived activity against HCV months prior to first dose of study drug
- hepatitis A or B, or HIV infection
- history or evidence of medical condition associated with chronic liver disease other
than HCV
We found this trial at
18
sites
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