Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan

Last updated: March 2, 2019
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Hepatitis

Nephropathy

Treatment

N/A

Clinical Study ID

NCT01766895
KMUH-IRB-980083
100CM-KMU-09
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • uremic patients

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 1600
Study Start date:
January 01, 2011
Estimated Completion Date:
January 31, 2021

Study Description

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.

Connect with a study center

  • Kaohsiung Medical University Hospital

    Kaohsiung, 886
    Taiwan

    Active - Recruiting

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