Treatment of CKD Patients With HCV

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Confirmed pregnancy.

HCV-HIV co infection.

HBV-HCV co infection.

Unstable CKD patients.

Trial design

Treatments tested in this trial

  • SOF+DCV
  • OBV/PTV/r) ± ribavirin (RBV)

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators