Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| uremic patients blood sampling of viral hepatitis in uremic patients |
Other: blood sampling
blood sampling of viral hepatitis to determined seroprevalence in uremic patients
|
Outcome Measures
Primary Outcome Measures
- seroprevalence of viral hepatitis in uremic patients [10 years]
Secondary Outcome Measures
- factors associated with HCV clearance or reappearance [10 years]
Other Outcome Measures
- HBV seroconversion [10 years]
Factors assocaited with HBV seroconversion
Eligibility Criteria
Criteria
Inclusion Criteria:
- uremic patients
Exclusion Criteria:
- Nil
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaohsiung Medical University Hospital | Kaohsiung | Taiwan | 886 |
Sponsors and Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
- Principal Investigator: Chung-Feng Huang, M.D., Kaohsiung Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KMUH-IRB-980083
- 100CM-KMU-09