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

NCT ID: NCT01168856

Last Updated: 2016-03-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

734 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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La Jolla, California, United States

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Long Beach, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Englewood, Colorado, United States

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Bradenton, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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New Orleans, Louisiana, United States

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Detroit, Michigan, United States

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Kansas City, Missouri, United States

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Lebanon, New Hampshire, United States

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Hillsborough, New Jersey, United States

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Newark, New Jersey, United States

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Manhasset, New York, United States

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New York, New York, United States

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New York, New York, United States

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Providence, Rhode Island, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Vancouver, Washington, United States

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Darlinghurst, New South Wales, Australia

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Kingswood, New South Wales, Australia

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Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Greenslopes, Queensland, Australia

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Herston, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Melbourne, Victoria, Australia

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Melbourne, Victoria, Australia

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Vienna, , Austria

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Salvador, Estado de Bahia, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Ribeirão Preto, São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Clichy, , France

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Créteil, , France

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Lille, , France

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Marseille, , France

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Montpellier, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Rennes, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt am Main, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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München, , Germany

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Bari, Apulia, Italy

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Napoli, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Pavia, Lombardy, Italy

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Turin, Piedmont, Italy

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Pisa, Tuscany, Italy

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Monterrey, , Mexico

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Christchurch, , New Zealand

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Dunedin, , New Zealand

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Grafton, , New Zealand

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Bydgoszcz, , Poland

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Chorzów, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Mysłowice, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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San Juan, , Puerto Rico

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Bratislava, , Slovakia

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Palma de Mallorca, Balearic Islands, Spain

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Santander, Cantabria, Spain

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A Coruña, La Coruña, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Pontevedra, Pontevedra, Spain

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Seville, Sevilla, Spain

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San Cristóbal de La Laguna, Tenerife, Spain

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Valencia, Valencia, Spain

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Dorset, , United Kingdom

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Dundee, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Australia Austria Brazil Canada France Germany Italy Mexico New Zealand Poland Puerto Rico Slovakia Spain United Kingdom

Other Identifiers

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2009-016560-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NV22688

Identifier Type: -

Identifier Source: org_study_id

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