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
Information provided by:
Hoffmann-La Roche Identifier:
First received: July 15, 2010
Last updated: September 19, 2011
Last verified: September 2011

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.

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)


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


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 identifier: NCT01168856

Contact: Please reference Study ID Number: NV22688 888-662-6728 (U.S. Only)

  Hide Study Locations
United States, California
Not yet recruiting
La Jolla, California, United States, 92037-1030
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
Aurora, Colorado, United States, 80045
United States, Florida
Bradenton, Florida, United States, 34209
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Hawaii
Not yet recruiting
Honolulu, Hawaii, United States, 96814
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Maryland
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Lutherville, Maryland, United States, 21093
United States, Missouri
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Kansas City, Missouri, United States, 64131
United States, New Jersey
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Newark, New Jersey, United States, 07102
United States, New York
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New York, New York, United States, 10021
United States, Rhode Island
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Providence, Rhode Island, United States, 02905
United States, Tennessee
Nashville, Tennessee, United States, 37211
United States, Texas
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Fort Sam Houston, Texas, United States, 78234-3879
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Houston, Texas, United States, 77030
United States, Virginia
Not yet recruiting
Richmond, Virginia, United States, 23249
Not yet recruiting
Greenslopes, Australia, 4120
Herston, Australia, 4029
Melbourne, Australia, 3181
Sydney, Australia, 2050
Not yet recruiting
Woolloongabba, Australia, 4102
Wien, Austria, 1080
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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Edmonton, Alberta, Canada, T6G 2B7
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Edmonton, Alberta, Canada, T6L5X8
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver, British Columbia, Canada, V6Z 2K5
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Vancouver, British Columbia, Canada, V5Z 1M9
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Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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London, Ontario, Canada, N6A 5A5
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5T 2S8
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Toronto, Ontario, Canada, M5G 2C4
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Clichy, France, 92118
Not yet recruiting
Montpellier, France, 34094
Not yet recruiting
Pessac, France, 33604
Not yet recruiting
Vandoeuvre-les-nancy, France, 54511
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
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München, Germany, 81377
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
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Auckland, New Zealand, 1150
Puerto Rico
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San Juan, Puerto Rico, 00927
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
Madrid, Spain, 28222
Not yet recruiting
Madrid, Spain, 28034
Sevilla, Spain, 41014
Not yet recruiting
Valencia, Spain, 46014
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche 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 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 processed this record on April 14, 2014