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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04695769
Recruitment Status : Completed
First Posted : January 5, 2021
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Mohammed Emadeldeen, Helwan University

Study Description
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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
Chronic Hepatitis C Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 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 : November 21, 2020
Actual Primary Completion Date : October 21, 2021
Actual Study Completion Date : October 21, 2021

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Arms and Interventions
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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 Name: 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 Name: Vosevi


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695769


Locations
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Egypt
Faculty of medicine Helwan University
Cairo, Egypt
Sponsors and Collaborators
Helwan University
More Information
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Responsible Party: Mohammed Emadeldeen, Hepato-gastroenterology specialist, Helwan University
ClinicalTrials.gov Identifier: NCT04695769    
Other Study ID Numbers: HelwanU 76-2020
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed Emadeldeen, Helwan University:
HCV
Relapse
treatment failure
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Flaviviridae Infections
Chronic Disease
Disease Attributes
Pathologic Processes
Ribavirin
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents