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.

ClinicalTrials.gov ID: NCT00377182

Public ClinicalTrials.gov record NCT00377182. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00377182
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 107 participants

Conditions and interventions

Conditions

Hepatitis C, Chronic

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2006 (Type not available)
Primary completion: Aug 2008 (Actual)
Completion: Aug 2008 (Actual)
Last update posted: Nov 2, 2016

2006 – 2008

United States locations

U.S. sites: 17
U.S. states: 9
U.S. cities: 16

Facility	City	State	ZIP	Site status
Not listed	La Jolla	California	92037-1030	—
Not listed	Long Beach	California	90822	—
Not listed	Sacramento	California	95817	—
Not listed	San Diego	California	92103-8465	—
Not listed	San Diego	California	92154	—
Not listed	San Francisco	California	94115	—
Not listed	Aurora	Colorado	80045	—
Not listed	Bradenton	Florida	34209	—
Not listed	Gainesville	Florida	32610-0214	—
Not listed	Chicago	Illinois	60637	—
Not listed	Novi	Michigan	48377	—
Not listed	Manhasset	New York	11030	—
Not listed	New York	New York	10029	—
Not listed	Chapel Hill	North Carolina	27599-7584	—
Not listed	Dallas	Texas	75203	—
Not listed	Fort Sam Houston	Texas	78234-3879	—
Not listed	Richmond	Virginia	23249	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00377182, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 2, 2016 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00377182 live on ClinicalTrials.gov.

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