A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

ClinicalTrials.gov ID: NCT01278134

Public ClinicalTrials.gov record NCT01278134. 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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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

Brief summary

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

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up. As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Study identification

NCT ID: NCT01278134
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 170 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: Jan 31, 2011
Primary completion: Sep 30, 2012
Completion: Sep 30, 2012
Last update posted: Nov 1, 2016

2011 – 2012

United States locations

U.S. sites: 18
U.S. states: 16
U.S. cities: 17

Facility	City	State	ZIP	Site status
Not listed	La Jolla	California	92037-1030	—
Not listed	Sacramento	California	95817	—
Not listed	Orlando	Florida	32809	—
Not listed	Marietta	Georgia	30060	—
Not listed	Honolulu	Hawaii	96814	—
Not listed	Honolulu	Hawaii	96817	—
Not listed	Chicago	Illinois	60637	—
Not listed	Indianapolis	Indiana	46202	—
Not listed	Lutherville	Maryland	21093	—
Not listed	Detroit	Michigan	48202	—
Not listed	Newark	New Jersey	07102	—
Not listed	Albuquerque	New Mexico	87131	—
Not listed	New York	New York	10021	—
Not listed	Providence	Rhode Island	02905	—
Not listed	Nashville	Tennessee	37211	—
Not listed	Houston	Texas	77030	—
Not listed	Newport News	Virginia	23602	—
Not listed	Vancouver	Washington	98664	—

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 14 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01278134, 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 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01278134 live on ClinicalTrials.gov.

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