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Treatment of CKD Patients With HCV

NCT07770984 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • HCV Infection ( Genotype 4) in CKD Patients

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2026-11-15
Completion
2027-05-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770984 on ClinicalTrials.gov