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Hepatitis CNCT03803410

Surveillance of HCV in Uremics and Linking to Medical Care

An observational study of Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HCV remains to prevail in the uremic patients under hemodialysis. The comprehensive surveillance in the risk population facilitates the link to care for HCV eradication. Read more about this study

Who is it for?
Ages 18 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis C
What is being tested?
blood test, noninvasive test for liver fibrosis
Type of treatment
Surgery or procedure
How many people
2,973 participants
Where
1 siteTaiwan
Study dates
7 Jan 2019to 20 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The FORMOSA-LIKE group is a collaborative alliance of Hepatology and Nephrology in Taiwan. It contains around 2000 uremic patients with maintenance hemodialysis in 21 hemodialysis units (one medical center, 4 regional core hospitals and 16 regional clinics). The current study plan to launch a universal surveillance of HCV in the cohort.

Who may be able to join

  • all uremic patients and medical staffs in the hemodialysis centers

Who cannot join

  • patients who refuse consents

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: Comprehensive Surveillance of HCV Infecion in Uremics Under Maintenance Hemodialysis and Linking to Medical Care in Taiwan

HCV remains to prevail in the uremic patients under hemodialysis. The comprehensive surveillance in the risk population facilitates the link to care for HCV eradication.

Read the detailed description
  1. Taiwan has the leading prevalence and incidence of end-stage renal disease (ESRD) worldwide. Uremic patients on maintenance hemodialysis (HD) are at great risk for hepatitis C virus (HCV) infection. The prevalence and annual incidence of HCV infection in ESRD patients undergoing hemodialysis have been reported to be 10%-59% and 0.2%-6.2%, respectively.
  2. HCV-related morbidities and mortality remain the major disease burden in the ESRD population. Uremic patients with HCV infection are associated with higher risk of excess risk of cardiovascular disease, hospitalization, worse quality of life, and mortality, and have more profound anemia compared to those without HCV infection..
  3. Imperatively, uremic patients remain at high risk of HCV new- or re-infection in the hemodialysis units.
  4. The investigators have performed a surveillance for prevalence of viral hepatitis in a collaborative group of Nephrologists and Hepatologists, the FORMOSA-LIKE group, which showed that the proportion of anti-HCV seropositivity in uremic patients is 15-19 % with the viremic rate of ~75% in Southern Taiwan in 2012. However, the update seroprevalence and disease severity of HCV infection among the uremic patients in the era of DAA in Taiwan is unknown. The current study aims to fully execute the surveillance program among the uremic population
  5. Participants with HCV infection will be directly linked to medical care without gap. The concept of micro-elimination in the high risk environment would help to facilitate WHO goal of HCV elimination by 2030.
  6. Understanding the potential drug-drug interaction (DDI) between directly acting antivirals (DAA) and co-medications for co-morbidities among uremic patients under maintenance hemodialysis would be helpful for decision-making when linking to care.
  7. Comprehensive surveillance and link-to-care among hemodialysis units might have great impact on the improvement of both liver-related (biochemical and virological responses, and hepatic fibrosis regression) and non-liver related outcomes (monthly erythropoietin requirement and quality of life), and the transfer rate of clean zoning among HCV-viremic patients.

All uremic participants will be tested for anti-HCV antibody. HCV virology including viral loads (and genotypes if RNA seropositivity) will be further tested in patients with anti-HCV seropositivity. All infected subjects will be evaluated for the liver fibrosis by non-invasive methods including fibroscan, FIB-4 and APRI and Serum WFA(+) -M2BP. All participants with chronic hepatitis C infection will be directly referred to the collaborative Hepatology Departments in one medical center and 5 regional core hospitals for HCV treatment. The outcome of HCV-related diseases, in terms of proportion of HCV micro-elimination in HD facilities, liver-related outcomes (biochemistry improvement [ ALT and AFP decline], sustained virological response rate, and hepatic fibrosis regression) and non-liver related outcomes [monthly erythropoietin requirement, and quality of life [SF36, HCV-CLDQ] ) will be evaluated 2 years after executing link-to-care strategy.

Year 1: Universal screen, confirmative determination of HCV viremia, genotyping and disease staging, education and link-to-care for HCV treatment in FORMOSA-LIKE collaborative alliances Year 2,3: Re-evaluate liver and non-liver related outcomes, and rate of HCV clean zoning among hemodialysis units.

Conditions
Hepatitis C
Being tested
blood test, noninvasive test for liver fibrosis
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood test, noninvasive test for liver fibrosisProcedure or surgery

    blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HCV prevalence

    To explore the current prevalence rate of hepatitis C virus (HCV) infection in uremic patients under maintenance hemodialysis in Taiwan

    Measured: 36 months

Secondary outcomes (4)

  1. liver fibrosis in HCV uremic patients

    To identify the severity of liver diseases in the uremic patients under maintenance hemodialysis by transient elastography

    Measured: 36 months

  2. Number of participants with potential drug-drug interaction with DAA

    To evaluate the patient number of potential drug-drug interactions (DDI) of co-medications with DAA by checking-up through the website, https://www.hep-druginteractions.org/

    Measured: 36 months

  3. Number of participants with hepatic outcome after HCV eradication

    incidence of HCC and fibrosis regression by Fibroscan after link-to-care to antiviral therapy

    Measured: 36 months

  4. Number of participants with extra-hepatic outcome after HCV eradication

    patients with improvement of quality of life by questionnaire SF36 and HCV-CLDQ

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2019
  2. Study start7 Jan 2019
  3. Primary completion20 May 2022
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,973 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03803410
Sponsor's protocol ID
KMUHIRB-E(I)-20180325
Status last verified
May 2022
First submitted
7 Jan 2019
Last updated
1 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang CF, Dai CY, Wang CW, Liang PC, Wei YJ, Tsai PC, Jang TY, Hsu PY, Jia-Jung Lee, Niu SW, Huang JC, Yeh ML, Huang CI, Hsieh MY, Lin YH, Chen SC, Chiu YW, Huang JF, Chang JM, Hwang SJ, Chuang WL, Yu ML; FORMOSA-LIKE investigators. Therapy as prevention toward HCV elimination in maintenance hemodialysis: a multi-center, prospective cohort study. Clin Kidney J. 2023 Jun 14;16(12):2429-2436. doi: 10.1093/ckj/sfad138. eCollection 2023 Dec.

    PubMed 38046041

  • 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

  • Yu ML, Huang CF, Wei YJ, Lin WY, Lin YH, Hsu PY, Hsu CT, Liu TW, Lee JJ, Niu SW, Huang JC, Hung TS, Yeh ML, Huang CI, Liang PC, Hsieh MY, Chen SC, Huang JF, Chang JM, Chiu YW, Dai CY, Hwang SJ, Chuang WL; FORMOSA-LIKE investigators. Establishment of an outreach, grouping healthcare system to achieve microelimination of HCV for uremic patients in haemodialysis centres (ERASE-C). Gut. 2021 Dec;70(12):2349-2358. doi: 10.1136/gutjnl-2020-323277. Epub 2020 Dec 10.

    PubMed 33303567

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HCV prevalence (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03803410, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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