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Completed

NCT Number: NCT03205618

A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar

The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.

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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, Doha, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients greater than or equal to 18 years of age
  • Diagnosed with chronic hepatitis C
  • Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015

Exclusion criteria

  • Use of a daclatasvir-containing regimen in a clinical trial setting

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12)

    Time frame: 12 weeks after the last dose of study treatment

    Patients will be considered to have achieved SVR12 if they have a documented undetectable viral load on or after Week 12 following the end of treatment.

Secondary outcomes

  1. Distribution of SVR12 by Treatment Regimen

    Time frame: 12 weeks after the last dose of study treatment

    Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.

  2. Distribution of SVR12 by Country

    Time frame: 12 weeks after the last dose of study treatment

    Defined as the country where treatment with a daclatasvir containing regimen was initiated. Subgroups include Saudi Arabia, UAE, and Qatar.

  3. Distribution of SVR12 by Genotype

    Time frame: 12 weeks after the last dose of study treatment

    Subgroups genotype 3 and genotype 4

  4. Distribution of SVR12 by HCV-Treatment Experience

    Time frame: 12 weeks after the last dose of study treatment

    Subgroups include patients in which prior treatment with IFN and RBV has failed; prior treatment with IFN, RBV and telaprevir or boceprevir has failed; previous treatment with IFN, RBV and simeprevir has failed; previous treatment with sofosbuvir and RBV has failed.

  5. Distribution of SVR12 by HIV co-infection

    Time frame: 12 weeks after the last dose of study treatment

    Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen.

  6. Distribution of SVR12 by previous liver transplantation

    Time frame: 12 weeks after the last dose of study treatment

    Subgroup defined by patients undergoing a liver transplant for any cause prior to the initiation of a daclatasvir containing regimen

  7. Incidence of Serious Adverse Events (SAE)

    Time frame: Up to 12 months

    Measured by number of patients reporting SAEs

  8. Incidence of Adverse Events leading to discontinuation

    Time frame: Up to 12 months

    Measured by number of patients reporting AEs that result in treatment discontinuation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Oct 11, 2017

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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