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NOT YET RECRUITING
NCT07770984
PHASE2/PHASE3

Treatment of CKD Patients With HCV

Sponsor: Tanta University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are: outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels. outcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment. If there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health. Participants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.

Official title: Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09-15

Completion Date

2027-05-15

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

SOF+DCV

25 CKD Patients with eGFR˃30ml/min with HCV infection and will receive one oral tablet of Sofosbuvir 400mg/day and one oral tablet of Daclatasvir 60mg/day for 12 weeks.

DRUG

OBV/PTV/r) ± ribavirin (RBV)

25 CKD Patients with eGFR≤30ml/min with HCV infection and will receive 2 oral tablets Qurevo®/day (Paritaprevir 150mg, Ombitasvir 25mg, Ritonavir 100mg ) and one oral capsule of Ribavirin 200mg for 12 weeks.

Locations (1)

Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral Committee

Tanta, Gharbia Governorate, Egypt