Clinical Trials Logo

Clinical Trial Summary

This is a retrospective, non-interventional study. Investigators from infectious diseases and gastroenterology departments will participate this study. Patients data will be collected from hospital medical records.


Clinical Trial Description

Pangenotypic Sofosbuvir/Velpatasvir/Voxilaprevir for 8-12 weeks has been shown highly effective, safe, and well-tolerated in treating patients with chronic HCV infection in clinical trial settings, however, there are no real-world setting data are available.This is the first opportunity from all over the world to demonstrate SOF/VEL/VOXs efficacy and safety in Real World setting especially for the naive patients. SOF/VEL/VOX is often positioned in retreatment by international guidelines. Previously the reimbursement guideline in Turkey did not allow patients to be re-treated after the failure of DAA treatments. With current guideline Vosevi is approved as the only option for failures of DAA treatments. In the past years in Turkey, SOF+RBV in GT2, SOF+PEF+RBV in GT3, LDV/SOF in GT1.4-6 patients and Viekirax/Exviera in GT1,4 patients have been used and unfortunately, some patients did not benefit from these suboptimal treatments. The efficacy and safety of SOF/VEL/VOX in patients who have experienced treatment failure in real life will be another objective of the research. This research will support 1. Efficacy and safety of 8-week Pangenotypic SOF/VEL/VOX for treatment naive non-cirrhotics 2. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for treatment naive compensate cirrhotics 3. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for retreatment of NS5A or NS3A4 and non-NS5A treatment-experienced patients (incl. noncirrhotics and cirrhotics) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06010524
Study type Observational
Source Cerrahpasa Medical Faculty Foundation
Contact Fehmi Tabak, Prof
Phone +905322763788
Email fehmitabak@yahoo.com
Status Recruiting
Phase
Start date February 1, 2023
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Recruiting NCT04510246 - Link Hepatitis C Notifications to Treatment in Tasmania N/A
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed NCT03118674 - Harvoni Treatment Porphyria Cutanea Tarda Phase 2
Completed NCT01458054 - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults Phase 1
Completed NCT03740230 - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Completed NCT00006301 - Immune Response to Hepatitis C Virus
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Recruiting NCT04405024 - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients N/A
Completed NCT04525690 - Improving Inpatient Screening for Hepatitis C N/A
Completed NCT04033887 - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn NCT04546802 - HepATocellular Cancer Hcv Therapy Study Phase 3
Active, not recruiting NCT02961426 - Strategic Transformation of the Market of HCV Treatments Phase 2/Phase 3
Completed NCT02992184 - PoC-HCV Genedrive Viral Detection Assay Validation Study N/A
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT03186313 - A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection Phase 3