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 - Full Text View

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Liver Diseases

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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 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 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 week intervals ] [ Designated as safety issue: No ]

Estimated Enrollment:	990
Study Start Date:	February 2012
Estimated Study Completion Date:	May 2017
Estimated Primary Completion Date:	May 2017 (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:

Received at least one dose of Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and completed participation in a previous study
1. Subjects participating in Daclatasvir (BMS-790052) and/or Asunaprevir (BMS-650032) studies may enroll regardless of virologic response (subjects who received control agents, eg, placebo, will be allowed to participate until unblinded treatment information is released for the parent protocol; at that time subjects will have the option to continue in the study)
2. Subjects participating in BMS-914143 (pegylated interferon lambda 1a) studies must have Hepatitis C virus (HCV) Ribonucleic acid (RNA) ≥ Limit of Quantitation (LOQ) at the completion of the post-treatment follow-up period
Enrolled within 6 months of completing previous study or within 6 months of protocol availability

Exclusion Criteria:

Treatment with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492504

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 96 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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:	April 30, 2012
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 June 18, 2013