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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03200379
• Other study ID #: irb20170053
• Status: Recruiting
• Start date: June 15, 2017
• Est. completion date: June 15, 2037

Study information

• Verified date: April 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Ming-Lung Yu, MD., PhD
• Phone: 88673121101
• Email: fish6069[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150000
• Est. completion date: June 15, 2037
• Est. primary completion date: June 15, 2037
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

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.

Locations

Country	Name	City	State
Taiwan	HepatobiliaryDivision, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients who have successfully eradicated HCV by DAAs	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	12 months