Comparing two hepatitis C drug regimens in people with chronic kidney disease
Tests two hepatitis C drug regimens in adults with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: Treatment of CKD Patients With HCV
Key facts
- Where
- Tanta, EgyptSee the site
- Phase
- Phase 2/3
Where in Egypt
- Tanta University, Internal Medicine Department, Nephrology and Dialysis Unite and Viral CommitteeTanta, EgyptNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tanta University
- Trial code
- NCT07770984
- Record updated
- 20 August 2026
- Original description
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:Read full original descriptionShow less
Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV
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.
Inclusion: Both male and female; Adults more than 18 years; Patients with CKD different stages stable on treatment with or without HD; HD Patients should be stable for at least 6 months under regular hemodialysis; Clinically stable condition as outpatients; Patients with HCV infections (serum positive for HCV GT4 with HCV RNA>1000 IU/ml by PCR); White blood cells count more than 2500/mm3; Platelet count more than 7500/mm3.
Exclusion: HCV-HIV co infection; HBV-HCV co infection; For patients without cirrhosis, Patients will be excluded if ALT or AST more than five times the upper limit of normal; For patients with cirrhosis, Patients will be excluded if ALT or AST are higher than seven times the upper limit of normal; Confirmed pregnancy; Unstable CKD patients; Patients who are recently stabilized on HD (less than 6 months); Patients on peritoneal dialysis.