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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181074
• Other study ID #: AI444-330
• Status: Completed
• Start date: October 21, 2015
• Est. completion date: August 19, 2019

Study information

• Verified date: March 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Mexico	Local Institution	Benito Juarez	Distrito Federal
Mexico	Local Institution	Mexico, D.f.	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 24 months
Secondary	Distribution of Adverse Events by Age		Approximately 24 months
Secondary	Distribution of Adverse Events by Gender		Approximately 24 months
Secondary	Distribution of Adverse Events by Interruption or Switch of Medication		Approximately 24 months
Secondary	Distribution of Adverse Events by Concomitant Medication		Approximately 24 months
Secondary	Distribution of Adverse Events by Race		Approximately 24 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form