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

NCT ID: NCT00963885

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Placebo

Placebo in combination with standard doses of Pegasys and Copegus.

Group Type PLACEBO_COMPARATOR

Copegus

Intervention Type DRUG

1000 or 1200mg po daily for 24 or 48 weeks

Pegasys

Intervention Type DRUG

180micrograms sc weekly for 24 or 48 weeks

Placebo

Intervention Type DRUG

po for 12 weeks

Part 1: RO5190591 300mg po

RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.

Group Type EXPERIMENTAL

Copegus

Intervention Type DRUG

1000 or 1200mg po daily for 24 or 48 weeks

Pegasys

Intervention Type DRUG

180micrograms sc weekly for 24 or 48 weeks

RO5190591 (Danoprevir)

Intervention Type DRUG

300mg po q8h for 12 weeks

Part 1: RO5190591 600mg po

RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Group Type EXPERIMENTAL

Copegus

Intervention Type DRUG

1000 or 1200mg po daily for 24 or 48 weeks

Pegasys

Intervention Type DRUG

180micrograms sc weekly for 24 or 48 weeks

RO5190591 (Danoprevir)

Intervention Type DRUG

600mg po q12h for 12 weeks

Part 1: RO5190591 900mg po

RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Group Type EXPERIMENTAL

Copegus

Intervention Type DRUG

1000 or 1200mg po daily for 24 or 48 weeks

Pegasys

Intervention Type DRUG

180micrograms sc weekly for 24 or 48 weeks

RO5190591 (Danoprevir)

Intervention Type DRUG

900mg po q12h for 12 weeks

Part 2: Placebo

If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.

Group Type PLACEBO_COMPARATOR

Copegus

Intervention Type DRUG

1000 or 1200mg po daily for 24 or 48 weeks

Pegasys

Intervention Type DRUG

180micrograms sc weekly for 24 or 48 weeks

Placebo

Intervention Type DRUG

po for 24 weeks

Part 2: RO5190591 300mg po

If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Group Type EXPERIMENTAL

Copegus

Intervention Type DRUG

1000 or 1200mg po daily for 24 or 48 weeks

Pegasys

Intervention Type DRUG

180micrograms sc weekly for 24 or 48 weeks

RO5190591 (Danoprevir)

Intervention Type DRUG

300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks

Interventions

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Copegus

1000 or 1200mg po daily for 24 or 48 weeks

Intervention Type DRUG

Pegasys

180micrograms sc weekly for 24 or 48 weeks

Intervention Type DRUG

Placebo

po for 12 weeks

Intervention Type DRUG

Placebo

po for 24 weeks

Intervention Type DRUG

RO5190591 (Danoprevir)

300mg po q8h for 12 weeks

Intervention Type DRUG

RO5190591 (Danoprevir)

600mg po q12h for 12 weeks

Intervention Type DRUG

RO5190591 (Danoprevir)

900mg po q12h for 12 weeks

Intervention Type DRUG

RO5190591 (Danoprevir)

300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* chronic hepatitis C, genotype 1;
* treatment-naive.

Exclusion Criteria

* liver cirrhosis and other forms of liver disease;
* HIV infection;
* hepatocellular cancer;
* cardiac disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Phoenix, Arizona, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Sacramento, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Gainesville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Lombard, Illinois, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Detroit, Michigan, United States

Site Status

Manhasset, New York, United States

Site Status

New York, New York, United States

Site Status

Asheville, North Carolina, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Medford, Oregon, United States

Site Status

Lancaster, Pennsylvania, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Vancouver, Washington, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Kingswood, New South Wales, Australia

Site Status

Adelaide, South Australia, Australia

Site Status

Heidelberg, Victoria, Australia

Site Status

Vienna, , Austria

Site Status

Calgary, Alberta, Canada

Site Status

Edmonton, Alberta, Canada

Site Status

Edmonton, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Winnipeg, Manitoba, Canada

Site Status

Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Clichy, , France

Site Status

Marseille, , France

Site Status

Montpellier, , France

Site Status

Paris, , France

Site Status

Frankfurt am Main, , Germany

Site Status

Hamburg, , Germany

Site Status

Napoli, Campania, Italy

Site Status

Countries

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United States Australia Austria Canada France Germany Italy

References

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Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.

Reference Type DERIVED
PMID: 23811112 (View on PubMed)

Other Identifiers

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2009-009608-38

Identifier Type: -

Identifier Source: secondary_id

NV21075

Identifier Type: -

Identifier Source: org_study_id