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

NCT ID: NCT03067883

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-09
• Study Completion Date: 2018-07-31

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.

Conditions

Chronic Hepatitis c

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interventional Qurevo group

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 ).

Group Type: EXPERIMENTAL

Ombitasvir, Paritaprevir and Ritonavir

Intervention Type: DRUG

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 ).

Interventions

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 ).

Intervention Type: DRUG

Other Intervention Names

qurevo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mai Mohamed Naguib Abdelmen'em Mohamed

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai Mohamed Naguib Abd Elmen'em, B.pharm

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Maadi armed forces hospital

Cairo, Maadi, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Maadi armed forces hospital

Role: primary

002025265127

Other Identifiers

Master (No 142)

Identifier Type: -

Identifier Source: org_study_id