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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. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01168856
First received: July 15, 2010
Last updated: November 24, 2014
Last verified: November 2014

July 15, 2010
November 24, 2014
September 2010
January 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01168856 on ClinicalTrials.gov Archive Site
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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
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)

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

Serum specimens collected from patients with partial viral response or viral load rebound of viral response to monitor for resistance mutations in viral RNA

Probability Sample

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

Hepatitis C, Chronic
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Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
770
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: NV22688 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Australia,   Austria,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Slovakia,   Spain,   United Kingdom
 
NCT01168856
NV22688, 2009-016560-36
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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