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

NCT03181074 | Completed

• 1 other identifier: AI444-330
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

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

Interventions

Non-Interventional OTHER

Non-Interventional

CHC patients in Mexico

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic Hepatitis C who are being given daclatasvir for the treatment and cure of chronic Hepatitis C at the sentinel sites for the CNFV in Mexico. Patients will be treated according to the clinical judgment of the treating physician.

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Benito Juárez, Mexico City, 03900, Mexico

Location

Local Institution

Mexico City, Mexico City, 14050, Mexico

Location

Related Links

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

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 8, 2017
• Study Start: October 21, 2015
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

ME (2)