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Micro-elimination of Hepatitis C Virus Infection in Uremics

NCT03891550 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-07-10

No results posted yet for this study

Summary

There is a huge gap between the clinical efficacy and community effectiveness in the treatment of chronic hepatitis C in Taiwan. HCV infection prevails in uremic patients with the prevalence of \> 10 % in Taiwan.The current study will be executed in each participating hemodialysis centers by an outreach team of HCV treaters, treating all of the HCV-viremic uremia patients and HD staffs at the same time (group therapy) in each individual HD center (Erase-C campaign) with all oral directly-acting antivirals, to ensure the rates of diagnosis, accessibility, treatment and follow-up.The purpose of the study is to demonstrate a model of care using outreach HCV treaters by implementing the concept of "group therapy" with one-size-fit-all pangenotypic DAA regimen, 12 weeks of sofosbuvir/velpatasvir, in each individual hemodialysis center (Erase-C campaign) to achieve HCV micro-elimination.

Conditions

  • Hepatitis C

Interventions

DRUG

Epclusa

sofosbuvir (SOF) 400 mg/Velpatasvir(VEL) 100 mg fixed-dosage combination once-daily for 12 weeks for all HCV genotype patients with and without hepatic decompensation

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Ming-Lung Yu, MD.,PhD. · Kaohsiung Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2024-04-15
Completion
2024-04-15
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891550 on ClinicalTrials.gov