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 October 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: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

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


Estimated Enrollment: 770
Study Start Date: September 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168856

Contacts
Contact: Reference Study ID Number: NV22688 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 127 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01168856     History of Changes
Other Study ID Numbers: NV22688, 2009-016560-36
Study First Received: July 15, 2010
Last Updated: October 20, 2014
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014