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

Bristol-Myers Squibb (BMS)

Status: Withdrawn

Conditions: Hepatitis C

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03208322

AI447-121

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 1 patient group

DCV + ASV at a sentinel site

Description:

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.

Treatment:

Other: Non-Interventional