A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection

ClinicalTrials.gov ID: NCT00963885

Public ClinicalTrials.gov record NCT00963885. 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 Sep 2, 2026, 10:19 AM 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, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

Brief summary

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

This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

Study identification

NCT ID: NCT00963885
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 229 participants

Conditions and interventions

Conditions

Hepatitis C, Chronic

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
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: Jul 31, 2009
Primary completion: Dec 31, 2011
Completion: Dec 31, 2011
Last update posted: Nov 1, 2016

2009 – 2012

United States locations

U.S. sites: 24
U.S. states: 15
U.S. cities: 23

Facility	City	State	ZIP	Site status
Not listed	Phoenix	Arizona	85054	—
Not listed	Long Beach	California	90822	—
Not listed	Los Angeles	California	90045	—
Not listed	Sacramento	California	95817	—
Not listed	San Diego	California	92123	—
Not listed	San Diego	California	92154	—
Not listed	Aurora	Colorado	80045	—
Not listed	Gainesville	Florida	32610-0214	—
Not listed	Jacksonville	Florida	32256	—
Not listed	Orlando	Florida	32809	—
Not listed	Lombard	Illinois	60148	—
Not listed	New Orleans	Louisiana	70112	—
Not listed	Ann Arbor	Michigan	48109	—
Not listed	Detroit	Michigan	48202-2689	—
Not listed	Manhasset	New York	11030	—
Not listed	New York	New York	10029-6574	—
Not listed	Asheville	North Carolina	28801	—
Not listed	Chapel Hill	North Carolina	27599-7584	—
Not listed	Medford	Oregon	97504	—
Not listed	Lancaster	Pennsylvania	17604-3200	—
Not listed	San Antonio	Texas	78215	—
Not listed	Salt Lake City	Utah	84132	—
Not listed	Vancouver	Washington	98664	—
Not listed	Milwaukee	Wisconsin	53210	—

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 19 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00963885, 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 1, 2016 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00963885 live on ClinicalTrials.gov.

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