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.

A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00517439

Enrollment

516

Registered

2007-08-17

Start date

2007-12-31

Completion date

2010-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Brief summary

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.

Interventions

DRUGCopegus

1000/1200mg po daily for 24 weeks

DRUGPegasys

180 micrograms sc weekly for 24 weeks

DRUGRO4588161

1000mg po bid for 24 weeks

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

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.

Design outcomes

Primary

Measure	Time frame
Sustained virological response (SVR)	24 weeks post treatment end (ie weeks 48 or 72)

Secondary

Measure	Time frame
Virological response over time	Throughout study
SVR	12 weeks post treatment end (ie weeks 36 or 60)
Relapse rate	End of treatment (ie weeks 24 or 48)
Adverse events (AEs), laboratory parameters.	Throughout treatment

Countries

Australia, Austria, Canada, France, Germany, Italy, Puerto Rico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026