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

NCT ID: NCT01766895

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Uremia Viral Hepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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uremic patients

blood sampling of viral hepatitis in uremic patients

blood sampling

Intervention Type OTHER

blood sampling of viral hepatitis to determined seroprevalence in uremic patients

Interventions

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blood sampling

blood sampling of viral hepatitis to determined seroprevalence in uremic patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* uremic patients

Exclusion Criteria

* Nil
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chung-Feng Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chung-Feng Huang, MD

Role: primary

88673121101 ext. 7475

References

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Wei YJ, Hsu PY, Lee JJ, Niu SW, Huang JC, Hsu CT, Jang TY, Yeh ML, Huang CI, Liang PC, Lin YH, Hsieh MY, Hsieh MH, Chen SC, Dai CY, Lin ZY, Chen SC, Huang JF, Chang JM, Hwang SJ, Chuang WL, Huang CF, Chiu YW, Yu ML. Evolutionary seroepidemiology of viral hepatitis and the gap in hepatitis C care cascades among uraemic patients receiving haemodialysis in Taiwan-the Formosa-Like Group. J Viral Hepat. 2021 May;28(5):719-727. doi: 10.1111/jvh.13477. Epub 2021 Feb 13.

Reference Type DERIVED
PMID: 33533547 (View on PubMed)

Other Identifiers

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100CM-KMU-09

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KMUH-IRB-980083

Identifier Type: -

Identifier Source: org_study_id

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