NCT03803410

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,973

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3.4 years

First QC Date

January 7, 2019

Last Update Submit

May 26, 2022

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • HCV prevalence

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

    36 months

Secondary Outcomes (4)

  • liver fibrosis in HCV uremic patients

    36 months

  • Number of participants with potential drug-drug interaction with DAA

    36 months

  • Number of participants with hepatic outcome after HCV eradication

    36 months

  • Number of participants with extra-hepatic outcome after HCV eradication

    36 months

Interventions

blood test, noninvasive test for liver fibrosisPROCEDURE

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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • all uremic patients and medical staffs in the hemodialysis centers

You may not qualify if:

  • patients who refuse consents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 38046041DERIVED

  • 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.

    PMID: 33533547DERIVED

  • 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.

    PMID: 33303567DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ming-Lung Yu, MD.,PhD.

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 14, 2019

Study Start

January 7, 2019

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)