Trial record 1 of 1 for: NCT01057667

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A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01057667

First received: January 26, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2010

Last Updated Date

May 7, 2013

Start Date ^ICMJE

February 2010

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test) [ Time Frame: 24 weeks after last treatment dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01057667 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Virologic response over time [ Time Frame: weeks 4, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
Resistance profile of RO5024048 [ Time Frame: weeks 1-24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

Official Title ^ICMJE

A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

Brief Summary

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Drug: RO5024048
1000mg bid po, 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Drug: Ribavirin [Copegus]
1000mg or 1200mg po daily

Study Arm (s)

Experimental: A
Interventions:
- Drug: RO5024048
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: Ribavirin [Copegus]
Active Comparator: B
Interventions:
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: Ribavirin [Copegus]

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

168

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients, 18-70 years of age
hepatitis C, genotype 1 or 4, of over 6 months duration
treatment-naïve
negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

pregnant or breast feeding females or male partners of pregnant females
previous interferon or ribavirin based therapy or investigational anti-HCV agent
systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
hepatitis A or B, or HIV infection
history or evidence of medical condition associated with chronic liver disease other than HCV

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT01057667

Other Study ID Numbers ^ICMJE

NV22621

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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