An observational study in Uremia and Viral Hepatitis, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational
The linkage between viral hepatitis and renal failure is complex. The current study aims to exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan
Patients are prospectively recruited from 15 hemodialysis units including one medical center, 3 satellite hospitals and 11 local clinics in Taiwan. Patients who provided informed consents for blood tests including genetic study related to HCV spontaneous seroclearance are enrolled for analysis. All the eligible subjects are tested for both HCV antibodies (third-generation, enzyme immunoassay; Abbott Laboratories, North Chicago, IL) and hepatitis B surface antigen (HBsAg). HCV RNA is tested by polymerase chain reaction (Cobas Amplicor Hepatitis C Virus Test, V.2.0; Roche Diagnostics, Branchburg, New Jersey, USA; detection limit: 50 IU/ml) twice for at least 6 months apart if anti-HCV is positive to ensure chronicity of HCV infection. HBsAg is quantified with the use of a standard quantitative chemiluminescent microparticle immunoassay (ARCHITECT HBsAg, Abbott Diagnostics). The concentration of HBsAg in the specimen is determined using a previously generated Architect HBsAg calibration curve (range, 0.05-250 IU/mL). Samples with serum HBsAg titer >250 IU/mL were diluted at 1:20 and 1:500 with the Architect HBsAg diluent and retested to expand the upper limit of the dynamic range from 250 to 125,000 IU/mL. Serum HBV DNA is determined by a standardized automated quantitative PCR assay (Cobas Amplicor HBV Monitor; Roche Diagnostics; detection limit 200 copies/ml) if patients are seropositive for HBsAg.
53 studies on the registry are indexed under Uremia; 10 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 105 across 12 observational studies indexed under Uremia.
Browse Uremia studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 291 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Uremic patients will recruited from 15 hemodialysis units including one medical center, 3 satellite hospitals and 11 local clinics in Taiwan.
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Exclusion Criteria:
blood sampling of viral hepatitis in uremic patients
Other: blood sampling
blood sampling of viral hepatitis to determined seroprevalence in uremic patients
seroprevalence of viral hepatitis in uremic patients
Time frame: 10 years
factors associated with HCV clearance or reappearance
Time frame: 10 years
HBV seroconversion
Factors assocaited with HBV seroconversion
Time frame: 10 years
Started Jan 2011 (actual). Primary completion is estimated for Jan 2021, 120 months after the start.
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University Chung-Ho Memorial Hospital →