Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Enrollment
- 150000
- Locations
- 1
- Primary Endpoint
- percentage of patients who have successfully eradicated HCV by DAAs
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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