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

N/AWithdrawnNCT03208322

Bristol-Myers Squibb

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Hepatitis C

Interventions

Non-InterventionalOTHER

Non-Interventional

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Local Institution

Df, Mexico City, Mexico

Local Institution

Magdalena de las Salinas, Mexico City, Mexico

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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