Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Completed
- Conditions
- Hepatitis C
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- 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
- Subjects who received daclatasvir as part of a clinical trial.
- Subjects who received daclatasvir for any indication other than local approved.
- Contraindications included in the approved Mexican prescribing information.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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 Concomitant Medication Approximately 24 months Distribution of Adverse Events by Interruption or Switch of 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
Local Institution🇲🇽Mexico, D.f., Distrito Federal, Mexico