Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06010524
Other study ID # HEPCTURKEY_2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source Cerrahpasa Medical Faculty Foundation
Contact Fehmi Tabak, Prof
Phone +905322763788
Email fehmitabak@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Cerrahpasa Medical Faculty Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Cerrahpasa Medical Faculty Foundation

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sustained Virology Response 12 Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment From start date of treatment to 12 weeks after the completion of treatment
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 NCT03118674 - Harvoni Treatment Porphyria Cutanea Tarda Phase 2
Completed NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
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 NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02992184 - PoC-HCV Genedrive Viral Detection Assay Validation Study N/A
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3