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

NCT ID: NCT03200379

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-15

Study Completion Date

2037-06-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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directly acting antivirals (DAAs)

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1\. 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Lung Yu, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ming-Lung Yu, MD., PhD

Role: CONTACT

88673121101 ext. 7475

Facility Contacts

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Ming-Lung Yu, MD., PhD

Role: primary

88673121101 ext. 7475

Other Identifiers

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irb20170053

Identifier Type: -

Identifier Source: org_study_id

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