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

Sponsor
Helwan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04695769
Collaborator
(none)
400
1
2
12
33.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin
  • Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial
Actual Study Start Date :
Nov 21, 2020
Anticipated Primary Completion Date :
Nov 21, 2021
Anticipated Study Completion Date :
Nov 21, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Achievement of sustained virological response (SVR) [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.

Secondary Outcome Measures

  1. Tolerability [During 12 weeks of treatment]

    Tolerability assessment by reporting of treatment related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine Helwan University Cairo Egypt

Sponsors and Collaborators

  • Helwan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Emadeldeen, Hepato-gastroenterology specialist, Helwan University
ClinicalTrials.gov Identifier:
NCT04695769
Other Study ID Numbers:
  • HelwanU 76-2020
First Posted:
Jan 5, 2021
Last Update Posted:
Jan 5, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohammed Emadeldeen, Hepato-gastroenterology specialist, Helwan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2021