Efficacy and Safety of Qurevo Plus Ribavirin Based Therapy for Hepatitis C With or Without Cirrhosis in Haemodialysis Patients

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

1. Under regular HD for at least 6 months

2. Clinically stable condition as outpatients.

3. Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR.

4. White blood cell count > 2500/mm^3.

5. Platelet count > 7500/mm^3.

6. Patients categorised as having compensated cirrhosis had a diagnosis of cirrhosis based on a previous screening liver FibroTest score of 0·72 or lower (eg, Metavir Fibrosis Score >3 [including 3/4 or 3-4] ).

Exclusion Criteria:

1. Confirmed pregnancy.

2. HCV-HIV co infection.

3. HBV-HCV co infection.

4. Uncontrolled hyper or hypothyroidism.

5. For patients without cirrhosis, Patients will be excluded if alanine or aspartate aminotransferase more than five times the upper limit of normal, for patients with cirrhosis they will be excluded if alanine or aspartate aminotransferase are higher than seven times the upper limit of normal

6. Patients on peritoneal dialysis.