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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01766895
First received: January 1, 2013
Last updated: January 10, 2013
Last verified: December 2012
  Purpose

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 Intervention
Uremia
Viral Hepatitis
Other: blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • seroprevalence of viral hepatitis in uremic patients [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • factors associated with HCV clearance or reappearance [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • HBV seroconversion [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Factors assocaited with HBV seroconversion


Biospecimen Retention:   Samples With DNA

host factors ssociated with viral hepatitis


Estimated Enrollment: 1600
Study Start Date: January 2011
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
uremic patients
blood sampling of viral hepatitis in uremic patients
Other: blood sampling
blood sampling of viral hepatitis to determined seroprevalence in uremic patients

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Uremic patients will recruited from 15 hemodialysis units including one medical center, 3 satellite hospitals and 11 local clinics in Taiwan.

Criteria

Inclusion Criteria:

  • uremic patients

Exclusion Criteria:

  • Nil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766895

Locations
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 886
Contact: Chung-Feng Huang, MD    88673121101 ext 7475    fengcheerup@yahoo.com.tw   
Principal Investigator: Chung-Feng Huang, MD         
Principal Investigator: Ming-Lung Yu, PhD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Chung-Feng Huang, M.D. Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01766895     History of Changes
Other Study ID Numbers: KMUH-IRB-980083, 100CM-KMU-09
Study First Received: January 1, 2013
Last Updated: January 10, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
uremia
HBV
HCV
seroclearance

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014