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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 has been terminated.
(This study was terminated due to the decrease in percentage of participants.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01168856
First received: July 15, 2010
Last updated: February 12, 2016
Last verified: February 2016
  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:
  • Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).

  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • HCV RNA Levels in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • HCV RNA Levels in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • HCV RNA Levels in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • HCV RNA Levels in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • HCV RNA Levels in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.

  • Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Pulse Rate in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Percentage of participants who received any anti-HCV medication during the monitoring period was reported.

  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

  • Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

    Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.


  • Number of Participants With DNV Resistance Status-Clonal Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.


  • Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.


  • Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.


  • Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.


  • Number of Participants With STV Resistance Status-Clonal Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.

    Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.


  • Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.


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

Enrollment: 734
Study Start Date: September 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, California
La Jolla, California, United States, 92037-1030
Long Beach, California, United States, 90822
Sacramento, California, United States, 95817
Sacramento, California, United States, 95825
San Diego, California, United States, 92103-8465
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
Englewood, Colorado, United States, 80113
United States, Florida
Bradenton, Florida, United States, 34209
United States, Georgia
Atlanta, Georgia, United States, 30309
Decatur, Georgia, United States, 30033
Marietta, Georgia, United States, 30060
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City, Kansas, United States, 66160-7222
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Missouri
Kansas City, Missouri, United States, 64131
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
Newark, New Jersey, United States, 07102
United States, New York
Manhasset, New York, United States, 11030
New York, New York, United States, 10003
New York, New York, United States, 10021
United States, Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
Nashville, Tennessee, United States, 37211
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78212
San Antonio, Texas, United States, 78234
United States, Virginia
Newport News, Virginia, United States, 23602
Richmond, Virginia, United States, 23249
United States, Washington
Vancouver, Washington, United States, 98604
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
Kingswood, New South Wales, Australia, 2747
Sydney, New South Wales, Australia, 2050
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Greenslopes, Queensland, Australia, 4120
Herston, Queensland, Australia, 4029
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Melbourne, Victoria, Australia, 3181
Melbourne, Victoria, Australia, 3186
Austria
Wien, Austria, 1080
Brazil
Salvador, BA, Brazil, 40210-341
Porto Alegre, RS, Brazil, 90035-003
Ribeirao Preto, SP, Brazil, 14049-900
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Edmonton, Alberta, Canada, T6G 2B7
Edmonton, Alberta, Canada, T6L5X8
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver, British Columbia, Canada, V6Z 2C7
Vancouver, British Columbia, Canada, V6Z 2K5
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 1L7
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
France
Clichy, France, 92118
Creteil, France, 94010
Lille, France, 59037
Marseille, France, 13285
Montpellier, France, 34094
Montpellier, France, 34295
Nice, France, 06202
Paris, France, 75651
Paris, France, 75679
Pessac, France, 33604
Rennes, France, 35033
Toulouse, France, 31059
Vandoeuvre-les-nancy, France, 54511
Germany
Berlin, Germany, 10969
Berlin, Germany, 13353
Frankfurt Am Main, Germany, 60590
Hamburg, Germany, 20099
Hannover, Germany, 30625
Muenchen, Germany, 81377
Italy
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Milano, Lombardia, Italy, 20121
Milano, Lombardia, Italy, 20162
Pavia, Lombardia, Italy, 27100
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70124
Pisa, Toscana, Italy, 56124
Mexico
Guadalajara, Mexico, 44280
Guadalajara, Mexico, 44650
Monterrey, Mexico, 64710
New Zealand
Christchurch, New Zealand, 8011
Dunedin, New Zealand, 9016
Grafton, New Zealand, 1010
Poland
Bydgoszcz, Poland, 85-030
Chorzow, Poland, 41-500
Lodz, Poland, 91-357
Myslowice, Poland, 41-400
Warszawa, Poland, 01-201
Warszawa, Poland, 02-507
Wrocław, Poland, 50-349
Łodz, Poland, 91-347
Puerto Rico
San Juan, Puerto Rico, 00927
Slovakia
Bratislava, Slovakia, 831 01
Spain
Badalona, Barcelona, Spain, 08915
Santander, Cantabria, Spain, 39008
Palma de Mallorca, Islas Baleares, Spain, 07010
La Coruna, La Coruña, Spain, 15006
La Laguna, Tenerife, Spain, 38320
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Madrid, Spain, 28029
Madrid, Spain, 28034
Madrid, Spain, 28222
Pontevedra, Spain, 36071
Sevilla, Spain, 41014
Valencia, Spain, 46014
United Kingdom
Dorset, United Kingdom, BH7 7DW
Dundee, United Kingdom, DD1 9SY
London, United Kingdom, E1 1BB
London, United Kingdom, SE5 9RS
London, United Kingdom, SW17 0QT
London, United Kingdom, W2 1NY
Manchester, United Kingdom, M8 5RB
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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
Results First Received: December 30, 2015
Last Updated: February 12, 2016
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on December 07, 2016