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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-02-27

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No