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
  Purpose

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.


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 ]

Estimated Enrollment: 500
Study Start Date: September 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168856

Contacts
Contact: Please reference Study ID Number: NV22688 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, California
Not yet recruiting
La Jolla, California, United States, 92037-1030
Recruiting
Sacramento, California, United States, 95817
Not yet recruiting
San Diego, California, United States, 92103-8465
Not yet recruiting
San Francisco, California, United States, 94115
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Recruiting
Bradenton, Florida, United States, 34209
United States, Georgia
Recruiting
Marietta, Georgia, United States, 30060
United States, Hawaii
Not yet recruiting
Honolulu, Hawaii, United States, 96814
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Not yet recruiting
Lutherville, Maryland, United States, 21093
United States, Missouri
Not yet recruiting
Kansas City, Missouri, United States, 64131
United States, New Jersey
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Newark, New Jersey, United States, 07102
United States, New York
Not yet recruiting
New York, New York, United States, 10021
United States, Rhode Island
Not yet recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
Not yet recruiting
Fort Sam Houston, Texas, United States, 78234-3879
Not yet recruiting
Houston, Texas, United States, 77030
United States, Virginia
Not yet recruiting
Richmond, Virginia, United States, 23249
Australia
Not yet recruiting
Greenslopes, Australia, 4120
Recruiting
Herston, Australia, 4029
Recruiting
Melbourne, Australia, 3181
Recruiting
Sydney, Australia, 2050
Not yet recruiting
Woolloongabba, Australia, 4102
Austria
Recruiting
Wien, Austria, 1080
Canada, Alberta
Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
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Edmonton, Alberta, Canada, T6G 2B7
Not yet recruiting
Edmonton, Alberta, Canada, T6L5X8
Canada, British Columbia
Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1H2
Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Not yet recruiting
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Not yet recruiting
London, Ontario, Canada, N6A 5A5
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5T 2S8
Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
France
Not yet recruiting
Clichy, France, 92118
Not yet recruiting
Montpellier, France, 34094
Not yet recruiting
Pessac, France, 33604
Not yet recruiting
Vandoeuvre-les-nancy, France, 54511
Germany
Not yet recruiting
Berlin, Germany, 10969
Not yet recruiting
Frankfurt Am Main, Germany, 60590
Not yet recruiting
Freiburg, Germany, 79106
Not yet recruiting
Hamburg, Germany, 20099
Not yet recruiting
Hannover, Germany, 30623
Not yet recruiting
München, Germany, 81377
Italy
Not yet recruiting
Bari, Italy, 70124
Not yet recruiting
Bologna, Italy, 40138
Not yet recruiting
Milano, Italy, 20121
Not yet recruiting
Napoli, Italy, 80131
Not yet recruiting
Pavia, Italy, 27100
Not yet recruiting
Pisa, Italy, 56124
Not yet recruiting
Torino, Italy, 10126
New Zealand
Not yet recruiting
Auckland, New Zealand, 1150
Puerto Rico
Not yet recruiting
San Juan, Puerto Rico, 00927
Spain
Not yet recruiting
Badalona, Spain, 08915
Not yet recruiting
Barcelona, Spain, 08036
Not yet recruiting
Barcelona, Spain, 08003
Not yet recruiting
Granada, Spain, 18012
Not yet recruiting
La Coruna, Spain, 15006
Recruiting
Madrid, Spain, 28222
Not yet recruiting
Madrid, Spain, 28034
Recruiting
Sevilla, Spain, 41014
Not yet recruiting
Valencia, Spain, 46014
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, 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: September 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014