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Surveillance of HCV in Uremics and Linking to Medical Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03803410
Recruitment Status : Unknown
Verified January 2019 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C Procedure: blood test, noninvasive test for liver fibrosis

Detailed Description:
  1. 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.
  2. 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..
  3. Imperatively, uremic patients remain at high risk of HCV new- or re-infection in the hemodialysis units.
  4. 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
  5. 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.
  6. 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.
  7. 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Surveillance of HCV Infecion in Uremics Under Maintenance Hemodialysis and Linking to Medical Care in Taiwan
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: blood test, noninvasive test for liver fibrosis
    blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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,

  3. 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

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The FORMOSA-LIKE group is a collaborative alliance of Hepatology and Nephrology in Taiwan. It contains around 2000 uremic patients with maintenance hemodialysis in 21 hemodialysis units (one medical center, 4 regional core hospitals and 16 regional clinics). The current study plan to launch a universal surveillance of HCV in the cohort.

Inclusion Criteria:

all uremic patients and medical staffs in the hemodialysis centers

Exclusion Criteria:

  • patients who refuse consents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03803410

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Contact: Ming-Lung Yu, MD.,PhD. 88673121101 ext 7475
Contact: Alice Hsieh, Miss 88673121101 ext 7481

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Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Ming-Lung Yu, MD., PhD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Principal Investigator: Ming-Lung Yu, MD.,PhD. Kaohsiung Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital Identifier: NCT03803410    
Other Study ID Numbers: KMUHIRB-E(I)-20180325
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections