Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
NCT ID: NCT04695769
Last Updated: 2022-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
281 participants
INTERVENTIONAL
2020-11-21
2021-10-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
NCT03250910
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
NCT02822794
Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
NCT05092074
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT04211909
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
NCT02607735
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
Group B: SOF/VEL/VOX
Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily).
Another name: Vosevi
Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients with platelet count less than 50000/ mm³.
* Patients with HCC or extrahepatic malignancy.
* Pregnancy or inability to use an effective contraceptive method.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helwan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammed Emadeldeen
Hepato-gastroenterology specialist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of medicine Helwan University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HelwanU 76-2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.