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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • directly acting antivirals (DAAs)

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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