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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 10, 2014
Last verified: November 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

  Hide Study Locations
Locations
United States, California
Active, not recruiting
La Jolla, California, United States, 92037-1030
Active, not recruiting
Long Beach, California, United States, 90822
Active, not recruiting
Sacramento, California, United States, 95825
Recruiting
Sacramento, California, United States, 95817
Active, not recruiting
San Diego, California, United States, 92103-8465
Completed
San Francisco, California, United States, 94115
United States, Colorado
Active, not recruiting
Aurora, Colorado, United States, 80045
Terminated
Englewood, Colorado, United States, 80113
United States, Florida
Completed
Bradenton, Florida, United States, 34209
United States, Georgia
Terminated
Atlanta, Georgia, United States, 30309
Active, not recruiting
Decatur, Georgia, United States, 30033
Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Hawaii
Active, not recruiting
Honolulu, Hawaii, United States, 96814
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Active, not recruiting
Kansas City, Kansas, United States, 66160-7222
United States, Louisiana
Active, not recruiting
New Orleans, Louisiana, United States, 70112
United States, Michigan
Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Completed
Kansas City, Missouri, United States, 64131
United States, New Hampshire
Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Recruiting
Hillsborough, New Jersey, United States, 08844
Completed
Newark, New Jersey, United States, 07102
United States, New York
Active, not recruiting
Manhasset, New York, United States, 11030
Terminated
New York, New York, United States, 10021
Completed
New York, New York, United States, 10003
United States, Rhode Island
Completed
Providence, Rhode Island, United States, 02905
United States, Tennessee
Active, not recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
Recruiting
Dallas, Texas, United States, 75246
Active, not recruiting
Houston, Texas, United States, 77030
Active, not recruiting
San Antonio, Texas, United States, 78234
Active, not recruiting
San Antonio, Texas, United States, 78212
United States, Virginia
Completed
Newport News, Virginia, United States, 23602
Active, not recruiting
Richmond, Virginia, United States, 23249
United States, Washington
Active, not recruiting
Vancouver, Washington, United States, 98604
Australia, New South Wales
Active, not recruiting
Darlinghurst, New South Wales, Australia, 2010
Active, not recruiting
Kingswood, New South Wales, Australia, 2747
Active, not recruiting
Sydney, New South Wales, Australia, 2050
Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Completed
Greenslopes, Queensland, Australia, 4120
Active, not recruiting
Herston, Queensland, Australia, 4029
Completed
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Completed
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Completed
Melbourne, Victoria, Australia, 3186
Completed
Melbourne, Victoria, Australia, 3181
Austria
Completed
Wien, Austria, 1080
Brazil
Active, not recruiting
Salvador, BA, Brazil, 40210-341
Active, not recruiting
Porto Alegre, RS, Brazil, 90035-003
Active, not recruiting
Ribeirao Preto, SP, Brazil, 14049-900
Canada, Alberta
Active, not recruiting
Calgary, Alberta, Canada, T2N 4Z6
Active, not recruiting
Edmonton, Alberta, Canada, T6L5X8
Completed
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada, V6Z 2C7
Active, not recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 1H2
Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Active, not recruiting
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Active, not recruiting
London, Ontario, Canada, N6A 5A5
Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Active, not recruiting
Toronto, Ontario, Canada, M5G 1L7
Active, not recruiting
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
France
Recruiting
Clichy, France, 92118
Recruiting
Creteil, France, 94010
Recruiting
Lille, France, 59037
Recruiting
Marseille, France, 13285
Recruiting
Montpellier, France, 34295
Active, not recruiting
Montpellier, France, 34094
Recruiting
Nice, France, 06202
Recruiting
Paris, France, 75651
Recruiting
Paris, France, 75679
Active, not recruiting
Pessac, France, 33604
Recruiting
Rennes, France, 35033
Active, not recruiting
Toulouse, France, 31059
Recruiting
Vandoeuvre-les-nancy, France, 54511
Germany
Active, not recruiting
Berlin, Germany, 13353
Active, not recruiting
Berlin, Germany, 10969
Active, not recruiting
Frankfurt Am Main, Germany, 60590
Active, not recruiting
Hamburg, Germany, 20099
Active, not recruiting
Hannover, Germany, 30625
Completed
Muenchen, Germany, 81377
Italy
Active, not recruiting
Napoli, Campania, Italy, 80131
Completed
Bologna, Emilia-Romagna, Italy, 40138
Terminated
Milano, Lombardia, Italy, 20162
Active, not recruiting
Milano, Lombardia, Italy, 20121
Terminated
Pavia, Lombardia, Italy, 27100
Active, not recruiting
Torino, Piemonte, Italy, 10126
Active, not recruiting
Bari, Puglia, Italy, 70124
Active, not recruiting
Pisa, Toscana, Italy, 56124
Mexico
Active, not recruiting
Guadalajara, Mexico, 44280
Active, not recruiting
Guadalajara, Mexico, 44650
Active, not recruiting
Monterrey, Mexico, 64710
New Zealand
Active, not recruiting
Christchurch, New Zealand, 8011
Active, not recruiting
Dunedin, New Zealand, 9016
Completed
Grafton, New Zealand, 1010
Poland
Recruiting
Bydgoszcz, Poland, 85-030
Active, not recruiting
Chorzow, Poland, 41-500
Recruiting
Lodz, Poland, 91-357
Active, not recruiting
Lodz, Poland, 91-347
Active, not recruiting
Myslowice, Poland, 41-400
Recruiting
Warszawa, Poland, 01-201
Completed
Warszawa, Poland, 02-507
Active, not recruiting
Wroclaw, Poland, 50-349
Puerto Rico
Terminated
San Juan, Puerto Rico, 00927
Slovakia
Active, not recruiting
Bratislava, Slovakia, 831 01
Spain
Active, not recruiting
Badalona, Barcelona, Spain, 08915
Active, not recruiting
Santander, Cantabria, Spain, 39008
Active, not recruiting
Palma de Mallorca, Islas Baleares, Spain, 07010
Completed
La Coruna, La Coruña, Spain, 15006
Active, not recruiting
La Laguna, Tenerife, Spain, 38320
Active, not recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08035
Active, not recruiting
Madrid, Spain, 28029
Active, not recruiting
Madrid, Spain, 28222
Active, not recruiting
Madrid, Spain, 28034
Active, not recruiting
Pontevedra, Spain, 36071
Active, not recruiting
Sevilla, Spain, 41014
Active, not recruiting
Valencia, Spain, 46014
United Kingdom
Active, not recruiting
Dorset, United Kingdom, BH7 7DW
Active, not recruiting
Dundee, United Kingdom, DD1 9SY
Active, not recruiting
London, United Kingdom, SE5 9RS
Active, not recruiting
London, United Kingdom, W2 1NY
Active, not recruiting
London, United Kingdom, SW17 0QT
Active, not recruiting
London, United Kingdom, E1 1BB
Active, not recruiting
Manchester, United Kingdom, M8 5RB
Active, not recruiting
Nottingham, United Kingdom, NG7 2UH
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: November 10, 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 November 20, 2014