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OpenTrials
Completed

NCT Number: NCT03145844

Direct Acting Agents in Hepatitis C Patients

This study is a retrospective study conducted at 36 sites. Planned target patient number is 1000.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Recurrent Hepatitis C Relapse 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

Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

About this study

Approximately 36 centers will be included in Turkey. Centers will be selected from clinics of infection and clinical microbiology. The inclusion of 1000 patients was targeted. All data will be retrospectively collected from the medical records of the patients. Patient visit is not necessary.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who used direct acting agents for Hepatitis C

Exclusion criteria

  • Patients younger then 18 years

Treatment and study plan

Primary outcomes

  1. Disease management with direct acting agents

    Time frame: Beginning of treatment - 12 weeks after the treatment ended (36 weeks)

    To assess disease management of chronic hepatitis C patients using direct acting agents (DAA) at national level, especially change in HCVRNA levels 12 weeks after the 24 weeks treatment (SVR12)

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to 48 weeks

    Adverse event list according to CTCAE v.4.03

Sponsors and collaborators

Lead sponsor

Fehmi Tabak

Other

Collaborators

  • Viral Hepatitis Society

Registry information

Official study title

Evaluation of Efficacy and Safety of Direct Acting Agents in Hepatitis C Patients

Acronym: HEPCTURKEY

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Oct 1, 2019

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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