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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

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

Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, Relapse, treatment failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of medicine Helwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: SOF/VEL/VOX with RBV

Group B: SOF/VEL/VOX

Arm Description

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 400/100/100 mg tablets (single pill combination administered orally once daily). Another name: Vosevi

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04695769

First Posted

December 24, 2020

Last Updated

August 31, 2022

Sponsor

Helwan University

1. Study Identification

Unique Protocol Identification Number

NCT04695769

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

November 21, 2020 (Actual)

Primary Completion Date

October 21, 2021 (Actual)

Study Completion Date

October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

HCV, Relapse, treatment failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

281 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: SOF/VEL/VOX with RBV

Arm Type

Experimental

Arm Description

Arm Title

Group B: SOF/VEL/VOX

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Vosevi + RBV

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]

Other Intervention Name(s)

Vosevi

Intervention Description

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

Primary Outcome Measure Information:

Title

Achievement of sustained virological response (SVR)

Description

Time Frame

12 weeks post treatment

Secondary Outcome Measure Information:

Title

Tolerability

Description

Time Frame

During 12 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Faculty of medicine Helwan University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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