A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

Roche

Status and phase

Completed

Phase 2

Conditions

Hepatitis C, Chronic

Treatments

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00517439

NV19865

Details and patient eligibility

About

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment

516 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;
chronic liver disease consistent with CHC;
compensated liver disease.

Exclusion criteria

infection with any HCV genotype other than genotype 1;
previous treatment for CHC;
medical condition associated with chronic liver disease other than CHC;
HIV, hepatitis A, hepatitis B infection.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

516 participants in 7 patient groups

Group 1

Experimental group

Description:

Group 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).

Treatment:

Drug: Pegasys

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Drug: RO4588161

Group 2

Experimental group

Description:

Group 2 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).

Treatment:

Drug: Pegasys

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Drug: RO4588161

Group 3

Experimental group

Description:

Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks.

Treatment:

Drug: Pegasys

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Drug: RO4588161

Group 4

Experimental group

Description:

Group 4 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).

Treatment:

Drug: Pegasys

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Drug: RO4588161

Group 5

Experimental group

Description:

Group 5 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).

Treatment:

Drug: Pegasys

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Drug: RO4588161

Group 6

Experimental group

Description:

Group 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).

Treatment:

Drug: Pegasys

Drug: RO4588161

Drug: Pegasys

Drug: Copegus

Drug: RO4588161

Group 7

Active Comparator group

Description:

Standard of care (SOC)

Treatment:

Drug: Pegasys