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

Chronic Hepatitis c Clinical Trial

Official title:

Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir Plus Ribavirin Based Therapy for Chronic Hepatitis C With or Without Compensated Cirrhosis in Haemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03067883
• Other study ID #: Master (No 142)
• Status: Recruiting
• Phase: Phase 2
• First received: January 23, 2017
• Last updated: January 17, 2018
• Start date: November 9, 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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 an 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 ).

Locations

Country	Name	City	State
Egypt	Maadi armed forces hospital	Cairo	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response	The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12).	After 12 weeks after the last dose
Secondary	Treatment related withdrawal rate	To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.	during treatment period, average duration 3 months