Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
NCT Number: NCT03803410
HCV remains to prevail in the uremic patients under hemodialysis. The comprehensive surveillance in the risk population facilitates the link to care for HCV eradication.
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Notify Me18 year–95 year
All sexes
Observational
Kaohsiung City, 807, Taiwan
All uremic participants will be tested for anti-HCV antibody. HCV virology including viral loads (and genotypes if RNA seropositivity) will be further tested in patients with anti-HCV seropositivity. All infected subjects will be evaluated for the liver fibrosis by non-invasive methods including fibroscan, FIB-4 and APRI and Serum WFA(+) -M2BP. All participants with chronic hepatitis C infection will be directly referred to the collaborative Hepatology Departments in one medical center and 5 regional core hospitals for HCV treatment. The outcome of HCV-related diseases, in terms of proportion of HCV micro-elimination in HD facilities, liver-related outcomes (biochemistry improvement [ ALT and AFP decline], sustained virological response rate, and hepatic fibrosis regression) and non-liver related outcomes [monthly erythropoietin requirement, and quality of life [SF36, HCV-CLDQ] ) will be evaluated 2 years after executing link-to-care strategy.
Year 1: Universal screen, confirmative determination of HCV viremia, genotyping and disease staging, education and link-to-care for HCV treatment in FORMOSA-LIKE collaborative alliances Year 2,3: Re-evaluate liver and non-liver related outcomes, and rate of HCV clean zoning among hemodialysis units.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
all uremic patients and medical staffs in the hemodialysis centers
Exclusion criteria
blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis
Time frame: 36 months
To explore the current prevalence rate of hepatitis C virus (HCV) infection in uremic patients under maintenance hemodialysis in Taiwan
Time frame: 36 months
To identify the severity of liver diseases in the uremic patients under maintenance hemodialysis by transient elastography
Time frame: 36 months
To evaluate the patient number of potential drug-drug interactions (DDI) of co-medications with DAA by checking-up through the website, https://www.hep-druginteractions.org/
Time frame: 36 months
incidence of HCC and fibrosis regression by Fibroscan after link-to-care to antiviral therapy
Time frame: 36 months
patients with improvement of quality of life by questionnaire SF36 and HCV-CLDQ
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
Comprehensive Surveillance of HCV Infecion in Uremics Under Maintenance Hemodialysis and Linking to Medical Care in Taiwan
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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