Clinical trial NCT00377182: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AEs) and laboratory parameters.
timeFrame: Week 4, 8 and Week 72
Secondary outcomes:
measure: Plasma concentration of HCV polymerase inhibitor
timeFrame: Week 4 and 8
measure: Antiviral activity
timeFrame: Week 4, 8 and Week 72
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Novi
country: United States
state: Michigan
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: