A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.

A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00377182

Enrollment

107

Registered

2006-09-18

Start date

2006-09-30

Completion date

2008-08-31

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 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Interventions

DRUGCopegus

1000/1200mg po daily for 4 weeks

DRUGPEGASYS

180 micrograms sc weekly for 4 weeks

DRUGRO5024048 1500mg

1500mg po bid for 4 weeks

DRUGRO5024048 3000mg

3000mg po bid for 4 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; * CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1; * chronic liver disease consistent with CHC.

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
Adverse events (AEs) and laboratory parameters.	Week 4, 8 and Week 72

Secondary

Measure	Time frame
Plasma concentration of HCV polymerase inhibitor	Week 4 and 8
Antiviral activity	Week 4, 8 and Week 72

Countries

Puerto Rico, United States

Outcome results

None listed

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