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

Bristol-Myers Squibb10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C

Interventions

Non-InterventionalOTHER

Non-Interventional

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. 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.

Locations (2)

Local Institution

Benito Juárez, Mexico City, Mexico

Local Institution

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Number of Adverse Events

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