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

NCT03200379 | Recruiting

• 1 other identifier: irb20170053
• Study Type: observational
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

directly acting antivirals (DAAs) OTHER

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects would be those CHC patients who receive approved DAA in the daily practice. No clinical developing medications will be allocated patients. Baseline characteristics including viral status and basic demography will be evaluated before antiviral therapy. On treatment responses and adverse events will be and recorded during treatment period. The final treatment outcome defined as sustained virological response 12 weeks after treatment (SVR12) and safety profile will be then judged and evaluated. To explore the long-term outcome of the CHC patients receiving DAAs, patients will receive constant post-treatment outpatient department follow-up. All the interventions and follow-up strategy will be the same as other CHC patients who do not precipitate in the projects.

You may qualify if:

• \. Patients who are treated with DAA and have willingness to participate in this registry.

You may not qualify if:

• Chronic hepatitis C patients who are unwilling to participate in the study and do not provide written informed consent for participation.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

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

Kaohsiung City, 807, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

host genetic associated HCV related outcomes would be retrived provided by patient consents

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-Lung Yu, MD., PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Lung Yu, MD., PhD

CONTACT

88673121101; fish6069@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 27, 2017
• Study Start: June 15, 2017
• Primary Completion (Estimated): June 15, 2037
• Study Completion (Estimated): June 15, 2037
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)