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NCT04662138 Clinical Trial

Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse

Hepatitis C Clinical Trial

Official title:
Safety and Efficacy of Directly Acting Antiviral Agents in Genotype 4 Hepatitis C Virus Relapse Among Egyptian Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04662138
Other study ID # 0304769
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 24, 2020
Est. completion date May 28, 2022

Study information
Verified date August 2020
Source Alexandria University
Contact Ahmed Kamal
Phone 01279734654
Email Ahmed.Kamal@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis. Failing to achieve SVR after treatment requires another regimen for these experienced patients. Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 28, 2022
Est. primary completion date May 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor. Exclusion Criteria: - No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• directly acting antivirals
Different regimens given for genotype 4 relapse: Sofosbuvir/velpatasvir/voxilaprevir ±ribavirin; sofosbuvir/velpatasvir ±ribavirin; ombitasvir/paritaprevir/ritonavir+ ribavirin

Locations
Country Name City State
Egypt Alexandria University. Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sustained virological response 12 weeks after completion of treatment
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