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Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

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ClinicalTrials.gov Identifier: NCT03208322
Recruitment Status : Unknown
Verified August 2018 by Bristol-Myers Squibb.
Recruitment status was:  Not yet recruiting
First Posted : July 5, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican Health Authority's AE surveillance system during a specified 24-month study period. The secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico during a specified 24-month study period.

Condition or disease Intervention/treatment
Hepatitis C Other: Non-Interventional

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Group/Cohort Intervention/treatment
DCV + ASV at a sentinel site
patients with chronic hepatitis C (CHC) who are being given at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) for the treatment and cure of CHC at the sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico.
Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. The number of adverse events (AEs) reported by patients treated with at least one dose of daclatasvir (DCV) and at least one dose of asunaprevir (ASV) and reported to the Health Authority (HA) during a specified period. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. The adverse events (AEs) reported to the Health Authority (HA) during a specified period in table format identifying the report number, patient Identification number, and type of adverse event (AE). [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will include all patients receiving at least 1 dose of DCV and ASV at the selected sites during the specified 24 month study period. Included patients will be:

  • At least 18 years of age with CHC, Genotype(GT)-1
  • Treatment-naïve and treatment-experienced (null or partial) responders
  • Intolerant to interferon (IFN)
  • With or without cirrhosis
Criteria

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • at least 18 years of age with CHC, GT-1
  • treatment-naïve and treatment-experienced (null or partial) responders
  • intolerant to interferon (IFN)
  • with or without cirrhosis

Exclusion Criteria:

  • patients who received DCV and ASV as part of a clinical trial
  • patients who received DCV and ASV for any indication other than that which is locally approved
  • contraindications included in the approved Mexican prescribing information

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208322


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Locations
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Mexico
Local Institution
Df, Distrito Federal, Mexico, 10700
Contact: Site 0002         
Local Institution
Magdalena De Las Salinas, Distrito Federal, Mexico, 07760
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03208322    
Other Study ID Numbers: AI447-121
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic