Status:
UNKNOWN
Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Ministry of Health, Brazil
State Secretary of Health of Rio Grande do Sul
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pangenotyp...
Detailed Description
Scientific rationale It's estimated that 0.7% of the Brazilian population is infected with hepatitis C virus (HCV). In March 2018, the Ministry of Health defined all patients with HCV to be able to r...
Eligibility Criteria
Inclusion
- Have voluntarily signed the informed consent form;
- Chronic hepatitis C confirmed by positive HCV-RNA;
- Have been referred to specialized consultation in gastroenterology or infectious disease in the Brazilian Public Health System in Porto Alegre;
- Have previous fibrosis staging (eg. liver biopsy, Fibroscan®) or laboratory tests for APRI score calculation.
Exclusion
- Suspicion or diagnosis of cirrhosis based on:
- Hepatic elastography ≥12.5 kPa on Fibroscan®;
- APRI score ≥2.0;
- Clinical, ultrasound or endoscopic evidence of cirrhosis or portal hypertension;
- Previous HCV treatment with direct acting antivirals;
- HIV coinfection with antiretroviral treatment incompatible with HCV antivirals;
- Previous solid organ transplant;
- Significant comorbidity that may interfere with the HCV treatment
- Creatinine clearance \< 30 mL/min;
- Platelets \< 150.000/mL;
- Pregnant or breastfeeding female;
- Woman of childbearing age without use or that does not accept to use effective contraception during treatment and during the 30 days after treatment end;
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04039698
Start Date
August 23 2019
End Date
November 1 2021
Last Update
August 25 2021
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-007