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Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults | Clinical Trials | Clareo Health

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

NCT03181074•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Local Institution

Benito Juárez, Mexico City, Mexico

Local Institution

Mexico City, Mexico City, Mexico

Key Dates

Start Date

October 21, 2015

Primary Completion Date

August 19, 2019

Completion Date

August 19, 2019

Last Updated

March 18, 2020

Enrollment

ESTIMATED participants

Conditions

Hepatitis C

Interventions

Non-Interventional

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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