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.

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377182
• Other study ID #: PV18369
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2006
• Last updated: November 1, 2016
• Start date: September 2006
• Est. completion date: August 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Copegus
1000/1200mg po daily for 4 weeks
• PEGASYS
180 micrograms sc weekly for 4 weeks
• RO5024048 1500mg
1500mg po bid for 4 weeks
• RO5024048 3000mg
3000mg po bid for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs) and laboratory parameters.		Week 4, 8 and Week 72	No
Secondary	Plasma concentration of HCV polymerase inhibitor		Week 4 and 8	No
Secondary	Antiviral activity		Week 4, 8 and Week 72	No