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Hepatitis CNCT01492504

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

An observational study of Hepatitis C, run by Bristol-Myers Squibb at 161 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
How many people
1,850 participants
Where
161 sitesin 19 countries
Study dates
7 Feb 2012to 19 Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

161 sites in 19 countries.

161 sites in 19 countries

United States50 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18102

  • University Of Michigan

    Ann Arbor, Michigan, 48109

  • Metropolitan Research

    Annandale, Virginia, 22003

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • University Of Colorado Denver & Hospital

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211-2145

  • Digestive Disease Associates, P.A.

    Catonsville, Maryland, 21228

  • University Of North Carolina At Chapel Hill School Of Med

    Chapel Hill, North Carolina, 27599-7584

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Southern California Research Center

    Coronado, California, 92118

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Gastro One

    Germantown, Tennessee, 38138

  • Nyu Medical Center

    Great Neck, New York, 11021

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Liver Associates Of Texas

    Houston, Texas, 77030

  • MEDVAMC

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Scripps Clinic

    La Jolla, California, 92037

  • Keck Medical Center of USC, HCC 1

    Los Angeles, California, 90033

  • Peter J Ruane Md Inc

    Los Angeles, California, 90036

  • Anthony M. Mills Md Inc

    Los Angeles, California, 90069

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Ssm Health Dean Med Group

    Madison, Wisconsin, 53715

  • Gastrointestinal Specialists Of Georgia

    Marietta, Georgia, 30060

  • Schiff Center for Liver Diseases

    Miami, Florida, 33136

  • University Of Miami School Of Medicine

    Miami, Florida, 33136

  • Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, 36116

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520-8019

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Florida Hospital Transplant Center

    Orlando, Florida, 32804

  • University Of Pennsylvania School Of Medicine

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Bon Secours St. Mary's Hospital of Richmond, Inc.

    Richmond, Virginia, 23226

  • Mcguire Dvamc

    Richmond, Virginia, 23249

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Precision Research Institute, Llc

    San Diego, California, 92114

  • Quest Clinical Research

    San Diego, California, 92120

  • Medical Associates Research Group

    San Diego, California, 92123

  • U.Cal.-San Francisco

    San Francisco, California, 94143

  • Southwest Care Center

    Santa Fe, New Mexico, 87505

  • Harborview Medical Center

    Seattle, Washington, 98104

  • The Research Institute

    Springfield, Massachusetts, 01105

  • Saint Louis University

    St Louis, Missouri, 63104

  • Carolinas Center For Liver Disease

    Statesville, North Carolina, 28677

  • Mayo Clinic Rochester

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

Other trials in United States

Japan24 sites

  • Local Institution

    Amagasaki-shi, Hyōgo, 6608511

  • Local Institution

    Bunkyo-ku, Tokyo, 1138655

  • Local Institution

    Chiba, Chiba, 2608677

  • Local Institution

    Chuo-shi, Yamanashi, 4093898

  • Local Institution

    Fukuoka, Fukuoka, 8108563

  • Local Institution

    Hiroshima, Hiroshima, 7340037

  • Local Institution

    Iruma-gun, Saitama, 3500495

  • Local Institution

    Kagoshima, Kagoshima-ken, 8908520

  • Local Institution

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution

    Kawasaki-shi, Kanagawa, 2138587

  • Local Institution

    Kurume, Fukuoka, 8300011

  • Local Institution

    Minato-ku, Tokyo, 1058470

  • Local Institution

    Musashino-shi, Tokyo, 1808610

  • Local Institution

    Nagoya, Aichi-ken, 4668560

  • Local Institution

    Ogaki-shi, Gifu, 5038502

  • Local Institution

    Okayama, Okayama-ken, 7008558

  • Local Institution

    Osaka, Osaka, 5458586

  • Local Institution

    Osaka-sayama-shi, Osaka, 5898511

  • Local Institution

    Sapporo, Hokkaido, 0600033

  • Local Institution

    Sendai, Miyagi, 9808574

  • Local Institution

    Shinagawa-ku, Tokyo, 1428666

  • Local Institution

    Suita, Osaka, 5640013

  • Local Institution

    Suita-shi, Osaka, 5650871

  • Local Institution

    Takamatsu, Kagawa-ken, 7608557

Other trials in Japan

France15 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94010

  • Local Institution

    La Roche-sur-Yon, 85925

  • Local Institution

    Lille, 59037

  • Local Institution

    Limoges, 87042

  • Local Institution

    Lyon, 69317

  • Local Institution

    Marseille, 13285

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nice, 06202

  • Local Institution

    Paris, 75571

  • Local Institution

    Paris, 75651

  • Local Institution

    Paris, 75679

  • Local Institution

    Pessac, 33604

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain11 sites

  • Local Institution

    Alicante, 03010

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Barcelona, 08916

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28046

  • Local Institution

    Madrid, 28222

  • Local Institution

    Madrid, 28922

  • Local Institution

    Málaga, 29071

  • Local Institution

    Santiago de Compostela, 15706

  • Local Institution

    Seville, 41014

  • Local Institution

    Valencia, 46010

Other trials in Spain

Australia9 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Clayton Vic, Victoria, 3168

  • Local Institution

    Darlinghurst, New South Wales, 2010

  • Local Institution

    Darlinghurst Nsw, New South Wales, 2010

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Randwick, New South Wales, 2031

  • Local Institution

    Westmead, New South Wales, 2145

  • Local Institution

    Woollongabba, Queensland, 4102

Other trials in Australia

Canada8 sites

  • Local Institution

    Calgary, Alberta, T2N 4Z6

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Local Institution

    Regina, Saskatchewan, S4P 0W5

  • Local Institution

    Toronto, Ontario, M5G 2C4

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Local Institution

    Vancouver, British Columbia, V6Z 2C7

  • Local Institution

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Germany7 sites

  • Local Institution

    Düsseldorf, 40237

  • Local Institution

    Essen, 45122

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Hamburg, 20099

  • Local Institution

    Hanover, 30625

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Mainz, 55101

Other trials in Germany

Argentina6 sites

  • Local Institution

    Buenos Aires, 1119

  • Hospital Italiano De Buenos Aires

    Buenos Aires, C1181

  • Fundacion Cidea De Paraguay

    Ciudad de Buenos Aires, Buenos Aires, C1121ABE

  • Centro Oncologico Integral

    Mar del Plata, Buenos Aires, 7600

  • Instituto Centralizado De Asistencia E Investigacion Clinica

    Prov de Santa Fe, Santa Fe Province, 2000

  • Hospital Austral

    Prov. Buenos Aires, Buenos Aires, 1629

Other trials in Argentina

Italy6 sites

  • Local Institution

    Brescia, 25123

  • Local Institution

    Cisanello (pisa), 56124

  • Local Institution

    Milan, 20127

  • Local Institution

    Pavia, 27100

  • Local Institution

    Torino, 10126

  • Local Institution

    Viale Del Policlinico, 155, 00161

Other trials in Italy

United Kingdom5 sites

  • Gartnaval General Hospital

    Glasgow, G12 0YN

  • Kings College Hospital

    London, Greater London, SE5 9RS

  • Local Institution

    London, Greater London, SW17 0QT

  • Imperial College London

    London, Greater London, W2 1NY

  • North Manchester General Hospital

    Manchester, Greater Manchester, M8 6RL

Other trials in United Kingdom

Brazil4 sites

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Local Institution

    Rio de Janeiro, 20270-004

  • Local Institution

    Rio de Janeiro, 21040-000

  • Local Institution

    São Paulo, 04035-970

Other trials in Brazil

South Korea4 sites

  • Local Institution

    Busan, 47392

  • Local Institution

    Busan, 49241

  • Local Institution

    Busan, 602-715

  • Local Institution

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Mexico3 sites

  • Local Institution

    Cuernavaca, Morelos, 62260

  • Local Institution

    Guadalajara, Jalisco, 44160

  • Local Institution

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Denmark2 sites

  • Local Institution

    Hvidovre, 2650

  • Local Institution

    Odense, 5000

Other trials in Denmark

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin, Dublin

  • St. James'S Hospital

    Dublin, Dublin

Other trials in Ireland

Sweden2 sites

  • Local Institution

    Gothenburg, SE-416 85

  • Local Institution

    Stockholm, 141 86

Other trials in Sweden

Poland1 site

  • Local Institution

    Bialystok, 15-540

Other trials in Poland

Puerto Rico1 site

  • Local Institution

    San Juan, 00927

Other trials in Puerto Rico

Taiwan1 site

  • Local Institution

    Taichung, 40447

Other trials in Taiwan

About this study

Official title: 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.

Conditions
Hepatitis C
Being tested
Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)Drug

    Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)]

Study groups in NCT01492504
Study groupRoleWhat they receive
Subjects with chronic hepatitis CSubjects 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
Receives: Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Durability of Sustained viral response [SVR] (time to loss of virologic response)

    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)

    Measured: 24 or 48-week Intervals

Secondary outcomes (2)

  1. 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

    Measured: 24 or 48-week intervals

  2. Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality

    Measured: 24 or 48-week intervals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study start7 Feb 2012
  3. Primary completion16 Mar 2018
  4. Study completion19 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492504
Sponsor's protocol ID
AI444-046
Other IDs
2011-005287-21
Status last verified
Nov 2019
First submitted
30 Nov 2011
Last updated
27 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.

    PubMed 28941023

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by Bristol-Myers Squibb at 161 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Japan, France, Spain, Australia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Durability of Sustained viral response [SVR] (time to loss of virologic response) (time frame: 24 or 48-week Intervals). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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