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

Completed

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

• Registration Number: NCT03181074
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-21
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Primary Completion: 2019-08-19
• Study Completion: 2019-08-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.

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Exclusion Criteria

1. Subjects who received daclatasvir as part of a clinical trial.
2. Subjects who received daclatasvir for any indication other than local approved.
3. Contraindications included in the approved Mexican prescribing information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHC patients in Mexico	Non-Interventional	patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Approximately 24 months	adverse events (AEs) on treatment with DCV in patients with chronic hepatitis C treated by doctors at participating sentinel sites for the CNFV in Mexico

Secondary Outcome Measures

Name	Time	Method
Distribution of Adverse Events by Age	Approximately 24 months
Distribution of Adverse Events by Gender	Approximately 24 months
Distribution of Adverse Events by Interruption or Switch of Medication	Approximately 24 months
Distribution of Adverse Events by Concomitant Medication	Approximately 24 months
Distribution of Adverse Events by Race	Approximately 24 months

Trial Locations

Locations (1)

Local Institution; 🇲🇽 Mexico, D.f., Distrito Federal, Mexico