Roche trials database

Trial information

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

Status:

Completed

Protocol number:

PV18369

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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

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. Target sample size is 107.

Study phase:

II

Study type:

Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety study

Conditions:

• Hepatitis C, Chronic

Primary outcome:

1. AEs and laboratory parameters. Time frame: Week 4, 8 and Week 72

Key secondary outcomes:

1. Plasma concentration of HCV polymerase inhibitor Time frame: Week 4 and 8
2. Antiviral activity Time frame: Week 4, 8 and Week 72

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.

Gender:

Males or Females

Age limits:

Min: 18 Max: 65

Accepts healthy volunteers:

No

Anticipated start date:

September, 2006

Trial registration date:

07.08.2006

Date last updated:

10.06.2013

This trial was conducted at the following locations:

U.S.A.

• LA JOLLA, CA
• LONG BEACH, CA
• SACRAMENTO, CA
• SAN DIEGO, CA
• SAN FRANCISCO, CA
• AURORA, CO
• BRADENTON, FL
• GAINESVILLE, FL
• CHICAGO, IL
• NOVI, MI
• CHAPEL HILL, NC
• MANHASSET, NY
• NEW YORK, NY
• SANTURCE, PR
• DALLAS, TX
• FORT SAM HOUSTON, TX
• RICHMOND, VA

Link to trial result