- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03803410
Surveillance of HCV in Uremics and Linking to Medical Care
Comprehensive Surveillance of HCV Infecion in Uremics Under Maintenance Hemodialysis and Linking to Medical Care in Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Taiwan has the leading prevalence and incidence of end-stage renal disease (ESRD) worldwide. Uremic patients on maintenance hemodialysis (HD) are at great risk for hepatitis C virus (HCV) infection. The prevalence and annual incidence of HCV infection in ESRD patients undergoing hemodialysis have been reported to be 10%-59% and 0.2%-6.2%, respectively.
- HCV-related morbidities and mortality remain the major disease burden in the ESRD population. Uremic patients with HCV infection are associated with higher risk of excess risk of cardiovascular disease, hospitalization, worse quality of life, and mortality, and have more profound anemia compared to those without HCV infection..
- Imperatively, uremic patients remain at high risk of HCV new- or re-infection in the hemodialysis units.
- The investigators have performed a surveillance for prevalence of viral hepatitis in a collaborative group of Nephrologists and Hepatologists, the FORMOSA-LIKE group, which showed that the proportion of anti-HCV seropositivity in uremic patients is 15-19 % with the viremic rate of ~75% in Southern Taiwan in 2012. However, the update seroprevalence and disease severity of HCV infection among the uremic patients in the era of DAA in Taiwan is unknown. The current study aims to fully execute the surveillance program among the uremic population
- Participants with HCV infection will be directly linked to medical care without gap. The concept of micro-elimination in the high risk environment would help to facilitate WHO goal of HCV elimination by 2030.
- Understanding the potential drug-drug interaction (DDI) between directly acting antivirals (DAA) and co-medications for co-morbidities among uremic patients under maintenance hemodialysis would be helpful for decision-making when linking to care.
- Comprehensive surveillance and link-to-care among hemodialysis units might have great impact on the improvement of both liver-related (biochemical and virological responses, and hepatic fibrosis regression) and non-liver related outcomes (monthly erythropoietin requirement and quality of life), and the transfer rate of clean zoning among HCV-viremic patients.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
all uremic patients and medical staffs in the hemodialysis centers
Exclusion Criteria:
- patients who refuse consents
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HCV prevalence
Time Frame: 36 months
|
To explore the current prevalence rate of hepatitis C virus (HCV) infection in uremic patients under maintenance hemodialysis in Taiwan
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36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver fibrosis in HCV uremic patients
Time Frame: 36 months
|
To identify the severity of liver diseases in the uremic patients under maintenance hemodialysis by transient elastography
|
36 months
|
Number of participants with potential drug-drug interaction with DAA
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/
|
36 months
|
Number of participants with hepatic outcome after HCV eradication
Time Frame: 36 months
|
incidence of HCC and fibrosis regression by Fibroscan after link-to-care to antiviral therapy
|
36 months
|
Number of participants with extra-hepatic outcome after HCV eradication
Time Frame: 36 months
|
patients with improvement of quality of life by questionnaire SF36 and HCV-CLDQ
|
36 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Wei YJ, Hsu PY, Lee JJ, Niu SW, Huang JC, Hsu CT, Jang TY, Yeh ML, Huang CI, Liang PC, Lin YH, Hsieh MY, Hsieh MH, Chen SC, Dai CY, Lin ZY, Chen SC, Huang JF, Chang JM, Hwang SJ, Chuang WL, Huang CF, Chiu YW, Yu ML. Evolutionary seroepidemiology of viral hepatitis and the gap in hepatitis C care cascades among uraemic patients receiving haemodialysis in Taiwan-the Formosa-Like Group. J Viral Hepat. 2021 May;28(5):719-727. doi: 10.1111/jvh.13477. Epub 2021 Feb 13.
- Yu ML, Huang CF, Wei YJ, Lin WY, Lin YH, Hsu PY, Hsu CT, Liu TW, Lee JJ, Niu SW, Huang JC, Hung TS, Yeh ML, Huang CI, Liang PC, Hsieh MY, Chen SC, Huang JF, Chang JM, Chiu YW, Dai CY, Hwang SJ, Chuang WL; FORMOSA-LIKE investigators. Establishment of an outreach, grouping healthcare system to achieve microelimination of HCV for uremic patients in haemodialysis centres (ERASE-C). Gut. 2021 Dec;70(12):2349-2358. doi: 10.1136/gutjnl-2020-323277. Epub 2020 Dec 10.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-E(I)-20180325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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