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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01492504
First received: November 30, 2011
Last updated: July 9, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hepatitis C
Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Durability of Sustained viral response [SVR] (time to loss of virologic response) [ Time Frame: 24 or 48-week Intervals ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1850
Study Start Date: February 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)]

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  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: NCT01492504

  Show 145 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01492504     History of Changes
Other Study ID Numbers: AI444-046, 2011-005287-21
Study First Received: November 30, 2011
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Sanitary Risks Protection
New Zealand: Medsafe
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Swedish Data Inspection Board
Sweden: Swedish Research Council
Sweden: Swedish National Council on Medical Ethics
Sweden: The National Board of Health and Welfare
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 22, 2014