NCT04695769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 24, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

December 24, 2020

Last Update Submit

August 31, 2022

Conditions

Chronic Hepatitis C

Keywords

HCVRelapsetreatment failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Tolerability

    During 12 weeks of treatment

Study Arms (2)

Group A: SOF/VEL/VOX with RBV

EXPERIMENTAL

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

Group B: SOF/VEL/VOX

ACTIVE COMPARATOR

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]

Interventions

Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus RibavirinDRUG

Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.

Also known as: Vosevi + RBV
Group A: SOF/VEL/VOX with RBV
Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]DRUG

Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.

Also known as: Vosevi
Group B: SOF/VEL/VOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Helwan University

Cairo, Egypt

Location

Related Publications (1)

  • El-Kassas M, Emadeldeen M, Hassany M, Esmat G, Gomaa AA, El-Raey F, Congly SE, Liu H, Lee SS. A randomized-controlled trial of SOF/VEL/VOX with or without ribavirin for retreatment of chronic hepatitis C. J Hepatol. 2023 Aug;79(2):314-320. doi: 10.1016/j.jhep.2023.04.011. Epub 2023 Apr 23.

    PMID: 37088312DERIVED

MeSH Terms

Conditions

Hepatitis C, ChronicRecurrence

Interventions

Sofosbuvirvelpatasvirvoxilaprevirsofosbuvir velpatasvir voxilaprevir drug combinationRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hepato-gastroenterology specialist

Study Record Dates

First Submitted

December 24, 2020

First Posted

January 5, 2021

Study Start

November 21, 2020

Primary Completion

October 21, 2021

Study Completion

October 21, 2021

Last Updated

September 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)