Evaluating the effectiveness of SOF/VEL/VOX in treating chronic Hepatitis C
A Retrospective Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX: Real Life Study
This study is trying to see how well a new combination treatment for chronic Hepatitis C works for people who have never been treated before and those who have not had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cerrahpasa Medical Faculty Foundation Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06010524 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze data from patients with chronic Hepatitis C who have been treated with the pangenotypic regimen of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX). The study will focus on assessing the efficacy and safety of this treatment in both treatment-naive patients and those who have previously failed other therapies. Data will be gathered retrospectively from hospital medical records, providing insights into real-world outcomes that have not been previously documented. The research will also evaluate the treatment's effectiveness in patients with varying degrees of liver disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with chronic Hepatitis C who have received SOF/VEL/VOX treatment.
Not a fit: Patients with decompensated cirrhosis, hepatocellular carcinoma (HCC), or an estimated glomerular filtration rate (eGFR) less than 30 ml/min may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable real-world evidence supporting the use of SOF/VEL/VOX as an effective treatment option for chronic Hepatitis C patients.
How similar studies have performed: While this study is novel in its focus on real-world data for SOF/VEL/VOX, similar studies have shown positive outcomes for other Hepatitis C treatments in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed as chronic hepatitis C and aged 18 and older * Patients received SOF/VEL/VOX treatment Exclusion Criteria: * Decompensated cirrhotic HCV patients * Having HCC * eGFR\<30 ml/min
Where this trial is running
Istanbul
- Cerrahpasa Medical Faculty — Istanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Fehmi Tabak, Prof — Cerrahpasa Medical Faculty
- Study coordinator: Fehmi Tabak, Prof
- Email: fehmitabak@yahoo.com
- Phone: +905322763788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.