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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01766895
Enrollment
1600
Registered
2013-01-11
Start date
2011-01-31
Completion date
2021-01-31
Last updated
2019-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremia, Viral Hepatitis

Keywords

uremia, HBV, HCV, seroclearance

Brief 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

Detailed 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.

Interventions

OTHERblood sampling

blood sampling of viral hepatitis to determined seroprevalence in uremic patients

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* uremic patients

Exclusion criteria

* Nil

Design outcomes

Primary

MeasureTime frame
seroprevalence of viral hepatitis in uremic patients10 years

Secondary

MeasureTime frame
factors associated with HCV clearance or reappearance10 years

Other

MeasureTime frameDescription
HBV seroconversion10 yearsFactors assocaited with HBV seroconversion

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026