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Trial ID AI447-121  |   NCT03208322

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

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Summary

  • Male and Female Gender icon
  • 18+
    Age Range
  • 2
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

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.

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Key Eligibility 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

DCV + ASV at a sentinel site

ASSIGNED INTERVENTION
  • Other: Non-Interventional
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