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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03181074
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Actual Duration (Months): 45.9
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Other: Non-Interventional

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
• Actual Study Start Date: Oct 21, 2015
• Actual Primary Completion Date: Aug 19, 2019
• Actual Study Completion Date: Aug 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
CHC patients in Mexico patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico	Other: Non-Interventional; Non-Interventional

Outcome Measures

Primary Outcome Measures

1. 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

1. Distribution of Adverse Events by Age [Approximately 24 months]

2. Distribution of Adverse Events by Gender [Approximately 24 months]

3. Distribution of Adverse Events by Interruption or Switch of Medication [Approximately 24 months]

4. Distribution of Adverse Events by Concomitant Medication [Approximately 24 months]

5. Distribution of Adverse Events by Race [Approximately 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Benito Juarez	Distrito Federal	Mexico	03900
2	Local Institution	Mexico, D.f.	Distrito Federal	Mexico	14050

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03181074
• Other Study ID Numbers: AI444-330
• First Posted: Jun 8, 2017
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis

Study Results

No Results Posted as of Mar 18, 2020