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NCT04695769 Clinical Trial

Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders

Chronic Hepatitis C Clinical Trial

Official title:
The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04695769
Other study ID # HelwanU 76-2020
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 21, 2020
Est. completion date October 21, 2021

Study information
Verified date August 2022
Source Helwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.

Recruitment information / eligibility
Status Completed
Enrollment 281
Est. completion date October 21, 2021
Est. primary completion date October 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (= 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment. Exclusion Criteria: - Patients with decompensated cirrhosis (Child-Pugh score B and C). - Patients with platelet count less than 50000/ mm³. - Patients with HCC or extrahepatic malignancy. - Pregnancy or inability to use an effective contraceptive method.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
• Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.

Locations
Country Name City State
Egypt Faculty of medicine Helwan University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Achievement of sustained virological response (SVR) Percentage of patients with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) SVR12 is defined as HCV RNA < the lower limit of quantitation 12 weeks following the last dose of study drug. 12 weeks post treatment
Secondary Tolerability Tolerability assessment by reporting any adverse events in addition to laboratory abnormalities via continuous monitoring of CBC, transaminases, serum bilirubin, and serum creatinine at baseline and every 4 weeks during treatment. During 12 weeks of treatment
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