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Completed

NCT Number: NCT03181074

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Benito Juárez, Mexico City, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Number of Adverse Events

    Time frame: 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 outcomes

  1. Distribution of Adverse Events by Age

    Time frame: Approximately 24 months

  2. Distribution of Adverse Events by Gender

    Time frame: Approximately 24 months

  3. Distribution of Adverse Events by Interruption or Switch of Medication

    Time frame: Approximately 24 months

  4. Distribution of Adverse Events by Concomitant Medication

    Time frame: Approximately 24 months

  5. Distribution of Adverse Events by Race

    Time frame: Approximately 24 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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