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

NCT03208322 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-05-27

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

OTHER

Non-Interventional

Non-Interventional

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-02-27
Completion
2019-02-27

Countries

  • Mexico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03208322 on ClinicalTrials.gov