An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

This study is currently recruiting participants.

Verified September 2011 by Hoffmann-La Roche

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01168856

First received: July 15, 2010

Last updated: September 19, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 15, 2010

Last Updated Date

September 19, 2011

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Persistence of DAA-associated resistant mutations following discontinuation of DAA therapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Durability of sustained virological response (SVR-24), defined as undetectable HCV RNA measured by Roche COBAS TaqMan HCV Test [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Collecting of serum specimens from patients with partial viral response or viral load rebound of viral response while on RO5024048 treatment, to monitor for resistance mutations in viral RNA [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Persistance of DAA-associated resistant mutations following discontinuation of DAA therapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Durability of sustained virological response (SVR-24), defined as undetectable HCV RNA measured by Roche COBAS TaqMan HCV Test [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Collecting of serum specimens from patients with partial viral response or viral load rebound of viral response while on RO5024048 treatment, to monitor for resistance mutations in viral RNA [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01168856 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

Official Title ^ICMJE

A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

Brief Summary

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Cohort

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

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

January 2016

Estimated Primary Completion Date

January 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients, >/=18 years of age
chronic hepatitis C
participation in Roche DAA treatment protocol for CHC infection
DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study

Exclusion Criteria:

For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: NV22688

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States, Australia, Austria, Canada, France, Germany, Italy, New Zealand, Puerto Rico, Spain

Administrative Information

NCT Number ^ICMJE

NCT01168856

Other Study ID Numbers ^ICMJE

NV22688, 2009-016560-36

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, 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

September 2011

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

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