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

Recruiting

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT03200379
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-08
• Primary Completion: 2037-06-15
• Study Completion: 2037-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of patients who have successfully eradicated HCV by DAAs	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

Trial Locations

Locations (1)

HepatobiliaryDivision, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; 🇨🇳 Kaohsiung, Taiwan