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

Uremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01766895
• Other study ID #: KMUH-IRB-980083
• Secondary ID: 100CM-KMU-09
• Status: Recruiting
• Start date: January 2011
• Est. completion date: January 2021

Study information

• Verified date: March 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• uremic patients

Exclusion Criteria:

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Uremia
• Viral Hepatitis

Intervention

Other:
• blood sampling
blood sampling of viral hepatitis to determined seroprevalence in uremic patients

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HBV seroconversion	Factors assocaited with HBV seroconversion	10 years
Primary	seroprevalence of viral hepatitis in uremic patients		10 years
Secondary	factors associated with HCV clearance or reappearance		10 years