Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

November 26, 2019 updated by: Bristol-Myers Squibb

A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1119
        • Local Institution
      • Buenos Aires, Argentina, C1181
        • Hospital Italiano de Buenos Aires
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Fundacion Cidea De Paraguay
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Centro Oncologico Integral
      • Prov. Buenos Aires, Buenos Aires, Argentina, 1629
        • Hospital Austral
    • Santa FE
      • Prov De Santa Fe, Santa FE, Argentina, 2000
        • Instituto Centralizado De Asistencia E Investigacion Clinica
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
      • Darlinghurst Nsw, New South Wales, Australia, 2010
        • Local Institution
      • Randwick, New South Wales, Australia, 2031
        • Local Institution
      • Westmead, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Woollongabba, Queensland, Australia, 4102
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australia, 3168
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
  • Brazil
      • Rio De Janeiro, Brazil, 20270-004
        • Local Institution
      • Rio De Janeiro, Brazil, 21040-000
        • Local Institution
      • Sao Paulo, Brazil, 04035-970
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-003
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Local Institution
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3M9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Local Institution
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Local Institution
  • Denmark
      • Hvidovre, Denmark, 2650
        • Local Institution
      • Odense, Denmark, 5000
        • Local Institution
  • France
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil Cedex, France, 94010
        • Local Institution
      • La Roche-sur-yon Cedex 9, France, 85925
        • Local Institution
      • Lille, France, 59037
        • Local Institution
      • Limoges, France, 87042
        • Local Institution
      • Lyon Cedex 04, France, 69317
        • Local Institution
      • Marseille Cedex 08, France, 13285
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Nice Cedex 03, France, 06202
        • Local Institution
      • PESSAC Cedex, France, 33604
        • Local Institution
      • Paris Cedex 12, France, 75571
        • Local Institution
      • Paris Cedex 13, France, 75651
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Toulouse Cedex 09, France, 31059
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Germany
      • Dusseldorf, Germany, 40237
        • Local Institution
      • Essen, Germany, 45122
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Hamburg, Germany, 20099
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Mainz, Germany, 55101
        • Local Institution
  • Ireland
    • Dublin
      • Dublin 3, Dublin, Ireland
        • Mater Misericordiae University Hospital
      • Dublin 8, Dublin, Ireland
        • St. James's Hospital
  • Italy
      • Brescia, Italy, 25123
        • Local Institution
      • Cisanello (pisa), Italy, 56124
        • Local Institution
      • Milano, Italy, 20127
        • Local Institution
      • Pavia, Italy, 27100
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
      • Viale Del Policlinico, 155, Italy, 00161
        • Local Institution
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4668560
        • Local Institution
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8108563
        • Local Institution
      • Kurume, Fukuoka, Japan, 8300011
        • Local Institution
    • Gifu
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 7340037
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0600033
        • Local Institution
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 6608511
        • Local Institution
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Local Institution
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 7608557
        • Local Institution
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8908520
        • Local Institution
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2138587
        • Local Institution
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
      • Suita, Osaka, Japan, 5640013
        • Local Institution
      • Suita-shi, Osaka, Japan, 5650871
        • Local Institution
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
      • Shinagawa-ku, Tokyo, Japan, 1428666
        • Local Institution
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 4093898
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Local Institution
      • Busan, Korea, Republic of, 47392
        • Local Institution
      • Busan, Korea, Republic of, 602-715
        • Local Institution
    • Gyeongsangnam-do
      • Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
        • Local Institution
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62260
        • Local Institution
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64710
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-540
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • Spain
      • Alicante, Spain, 03010
        • Local Institution
      • Barcelona, Spain, 08035
        • Local Institution
      • Barcelona, Spain, 08916
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
      • Madrid, Spain, 28222
        • Local Institution
      • Madrid, Spain, 28922
        • Local Institution
      • Malaga, Spain, 29071
        • Local Institution
      • Santiago De Compostela, Spain, 15706
        • Local Institution
      • Sevilla, Spain, 41014
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
  • Sweden
      • Gothenburg, Sweden, SE-416 85
        • Local Institution
      • Stockholm, Sweden, 141 86
        • Local Institution
  • Taiwan
      • Taichung, Taiwan, 40447
        • Local Institution
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Gartnaval General Hospital
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, Greater London, United Kingdom, SW17 0QT
        • Local Institution
      • London, Greater London, United Kingdom, W2 1NY
        • Imperial College London
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M8 6RL
        • North Manchester General Hospital
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • Beverly Hills, California, United States, 90211-2145
        • Pacific Oaks Medical Group
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC, HCC 1
      • Los Angeles, California, United States, 90036
        • Peter J Ruane Md Inc
      • Los Angeles, California, United States, 90069
        • Anthony M. Mills Md Inc
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92114
        • Precision Research Institute, LLC
      • San Diego, California, United States, 92120
        • Quest Clinical Research
      • San Francisco, California, United States, 94143
        • U.Cal.-San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado Denver & Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8019
        • Yale New Haven Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Transplant Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Ruth M. Rothstein CORE Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Catonsville, Maryland, United States, 21228
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest CARE Center
    • New York
      • Great Neck, New York, United States, 11021
        • NYU Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
        • University Of North Carolina At Chapel Hill School Of Med
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Statesville, North Carolina, United States, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Healthcare Research Consultants
      • Tulsa, Oklahoma, United States, 74104
        • Mayo Clinic Rochester
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Lehigh Valley Health Network
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of medicine
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas
      • Houston, Texas, United States, 77030
        • MEDVAMC
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Metropolitan Research
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Ssm Health Dean Med Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C

Description

Inclusion Criteria

  • Signed Written Informed Consent
  • Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
  • Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
  • Completed the required post-treatment follow-up period in previous study
  • Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
  • Men and women, ages 18 and older

Exclusion Criteria:

  • Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
  • Subject must not be participating in any other trial, excluding non-interventional trials
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with chronic hepatitis C
Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C
Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durability of Sustained viral response [SVR] (time to loss of virologic response)
Time Frame: 24 or 48-week Intervals
The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA)
24 or 48-week Intervals

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12
Time Frame: 24 or 48-week intervals
24 or 48-week intervals
Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality
Time Frame: 24 or 48-week intervals
24 or 48-week intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2012

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-046
  • 2011-005287-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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