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

August 31, 2022 updated by: Mohammed Emadeldeen, Helwan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Medicine Helwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A: SOF/VEL/VOX with RBV

Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily) plus Ribavirin (weight-based dose 1000 or 1200 mg daily according to patient body weight: < or > 60 kg).

Another name: Vosevi, RBV
Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
Other Names:
  • Vosevi + RBV
ACTIVE_COMPARATOR: Group B: SOF/VEL/VOX

Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily).

Another name: Vosevi
Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
Other Names:
  • Vosevi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of sustained virological response (SVR)
Time Frame: 12 weeks post treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability
Time Frame: During 12 weeks of treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2020

Primary Completion (ACTUAL)

October 21, 2021

Study Completion (ACTUAL)

October 21, 2021

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

January 3, 2021

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelwanU 76-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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