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Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

NCT04039698 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-08-25

No results posted yet for this study

Summary

The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment.

The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.

Conditions

  • Chronic Hepatitis C

Interventions

OTHER

Telemedicine

Telemedicine monitoring and teleconsultation by video calls

DRUG

Velpatasvir/Sofosbuvir

Velpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • State Secretary of Health of Rio Grande do Sul

    collaborator UNKNOWN

  • TelessaúdeRS / UFRGS

    collaborator UNKNOWN

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Mario R Alvares-da-Silva, PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-23
Primary Completion
2020-12-16
Completion
2021-11-30

Countries

  • Brazil

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 NCT04039698 on ClinicalTrials.gov