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Status unknownNCT01766895Updated Mar 5, 2019

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

An observational study in Uremia and Viral Hepatitis, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,600
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Uremia
  • Viral Hepatitis

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Keywords

  • uremia
  • HBV
  • HCV
  • seroclearance
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In context

Uremia

53 studies on the registry are indexed under Uremia; 10 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 105 across 12 observational studies indexed under Uremia.

Browse Uremia studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 291 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • uremic patients

Exclusion criteria

Exclusion Criteria:

  • Nil
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • uremic patients

    blood sampling of viral hepatitis in uremic patients

    Other: blood sampling

Interventions

  • Otherblood sampling

    blood sampling of viral hepatitis to determined seroprevalence in uremic patients

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What researchers measure

Primary outcomes

  1. seroprevalence of viral hepatitis in uremic patients

    Time frame: 10 years

Secondary outcomes

  1. factors associated with HCV clearance or reappearance

    Time frame: 10 years

Other outcomes

  1. HBV seroconversion

    Factors assocaited with HBV seroconversion

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Medical University Hospital
    Kaohsiung, 886, Taiwan
    Recruiting
    • Chung-Feng Huang, MD · Contactfengcheerup@yahoo.com.tw · 88673121101
    • Chung-Feng Huang, MD · Principal investigator
    • Ming-Lung Yu, PhD · Principal investigator
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References and documents

Publications

  • 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. PubMed 33533547 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2011 (actual). Primary completion is estimated for Jan 2021, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 1, 2013
First posted
Jan 11, 2013
StartActual
Jan 2011
Primary completionEst.
Jan 2021
CompletionEst.
Jan 2021
Last update
Mar 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01766895
Responsible party
Sponsor
First posted
Jan 11, 2013
Start date
Jan 2011
Primary completion
Jan 2021 (estimated)
Completion
Jan 2021 (estimated)
Last update
Mar 5, 2019

Study contacts

Chung-Feng Huang, M.D.
principal investigator · Kaohsiung Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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