A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive 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 - 65
Updated:8/3/2016
Start Date:February 2001
End Date:February 2012

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A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection

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.


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
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22
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New York, NY
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Birmingham, AL
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