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OpenTrials
Recruiting

NCT Number: NCT03200379

Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan

To determine the treatment efficacy, safety and long-term outcomes of chronic hepatitis C patients receiving directly acting antivirals in Taiwan

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

HepatobiliaryDivision, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

Kaohsiung City, 807, Taiwan

Location status: Recruiting

Location contact

Ming-Lung Yu, MD., PhD

CONTACT

[email protected]

88673121101 ext. 7475

Ming-Lung Yu, MD., PhD

PRINCIPAL_INVESTIGATOR

About this study

The National Health Insurance Administration (NHIA) in Taiwan supports the use of antivirals against CHC. Recently, the introduction of directly acting antivirals (DAA) has markedly improved the treatment adherence, efficacy and safety issues in well-designed clinical trials. However, the real world community effectiveness and long-term benefits of DAA for HCV treatments remain to be determined. Since the NHIA in Taiwan has reimbursed the DAA in the treatment of chronic hepatitis C (CHC) patients in the near future, establishment of a well prospectively designed registry policy is demanded in the national level to explore the unmet needs of HCV control in Taiwan. The primary purpose of the study is to establish a nationwide registry of patients undergoing antiviral treatment with DAA regimens for CHC at both academic and community practices. Based on this database, the clinical gaps regarding to treatment guidelines and management of adverse events will be identified. The registry system will be established as a research network and provide sufficient high-quality clinical information for investigators in Taiwan.

Who can participate

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

Inclusion criteria

  • Patients who are treated with DAA and have willingness to participate in this registry.

Exclusion criteria

Chronic hepatitis C patients who are unwilling to participate in the study and do not provide written informed consent for participation.

Treatment and study plan

directly acting antivirals (DAAs)

Other

Eligible subjects would be those CHC patients who receive approved DAA in the daily practice in Taiwan. No clinical developing medications will be allocated patients.

Primary outcomes

  1. percentage of patients who have successfully eradicated HCV by DAAs

    Time frame: 12 months

    To determine the treatment efficacy, defined as undetectable HCV RNA 12 weeks after end of therapy (sustained virological response 12 weeks after treatment, SVR12) of chronic hepatitis C patients receiving directly acting antivirals

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Lung Yu, MD., PhD

CONTACT

[email protected]

88673121101 ext. 7475

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2037
Study completion
2037
First posted
Jun 27, 2017
Registry last updated
Apr 8, 2022

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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