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

Phase 2

• Conditions: Chronic Hepatitis c
• Interventions: Drug: Ombitasvir, Paritaprevir and Ritonavir

• Registration Number: NCT03067883
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

The aim of this study is;

To evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis through assessment of:

1. The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).

2. To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.

Study Timeline

• Study Start: 2016-11-09
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-01
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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] ).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional Qurevo group	Ombitasvir, Paritaprevir and Ritonavir	A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study. * These patients will receive intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. * Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session). * Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session ).

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response	After 12 weeks after the last dose	The proportion of patients with a sustained virological response (HCV RNA \<25 IU/mL) 12 weeks after the last dose of study drug (SVR12).

Secondary Outcome Measures

Name	Time	Method
Treatment related withdrawal rate	during treatment period, average duration 3 months	To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.

Trial Locations

Locations (1)

Maadi armed forces hospital; 🇪🇬 Cairo, Maadi, Egypt