A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Pegasys; Drug: Copegus; Drug: RO5024048

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869661

NV20536

2008-008258-21

Details and patient eligibility

About

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.

Enrollment: 413 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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413 participants in 6 patient groups

Group 1

Experimental group

Description:

RO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.

Treatment:

Drug: Pegasys

Drug: Copegus

Drug: RO5024048

Drug: Pegasys

Drug: RO5024048

Drug: Copegus

Drug: RO5024048

Drug: RO5024048

Group 2

Experimental group

Description:

RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.

Treatment:

Drug: Pegasys

Drug: Copegus

Drug: RO5024048

Drug: Pegasys

Drug: RO5024048

Drug: Copegus

Drug: RO5024048

Drug: RO5024048

Group 3

Experimental group

Description:

RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.

Treatment:

Drug: Pegasys

Drug: Copegus

Drug: RO5024048

Drug: Pegasys

Drug: RO5024048

Drug: Copegus

Drug: RO5024048

Drug: RO5024048

Group 4

Experimental group

Description:

Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks

Treatment:

Drug: Pegasys

Drug: Copegus

Drug: RO5024048

Drug: Pegasys

Drug: RO5024048

Drug: Copegus

Drug: RO5024048

Drug: RO5024048

Group 5

Active Comparator group

Description:

Group 5 will receive SOC for 48 weeks

Treatment:

Drug: Pegasys

Drug: Copegus

Drug: Pegasys

Drug: Copegus

Group 6

Experimental group

Description:

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.

Treatment:

Drug: Pegasys

Drug: Copegus

Drug: RO5024048

Drug: Pegasys

Drug: RO5024048

Drug: Copegus

Drug: RO5024048

Drug: RO5024048