Nation-wide Hepatitis C Virus (HCV) Registry in Taiwan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: directly acting antivirals (DAAs).
- Who it may be relevant to
- Registry conditions: Hepatitis C, Chronic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- percentage of patients who have successfully eradicated HCV by DAAs [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- HepatobiliaryDivision, Department of Internal Medicine, Kaohsiung Medical University Hospi — Kaohsiung City
Identifiers
NCT: NCT03200379 · irb20170053