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

Withdrawn

• Conditions: Hepatitis C
• Interventions: Other: Non-Interventional

• Registration Number: NCT03208322
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2018-11-30
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DCV + ASV at a sentinel site	Non-Interventional	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.

Primary Outcome Measures

Name	Time	Method
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.	24 months

Secondary Outcome Measures

Name	Time	Method
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).	24 months

Trial Locations

Locations (1)

Local Institution; 🇲🇽 Magdalena De Las Salinas, Distrito Federal, Mexico