Hepatitis C
Conditions
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.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed