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

Primary Purpose

Chronic Hepatitis c

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Ombitasvir, Paritaprevir and Ritonavir

About this trial

This is an interventional treatment trial for Chronic Hepatitis c

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Under regular HD for at least 6 months
Clinically stable condition as outpatients.
Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR.
White blood cell count > 2500/mm^3.
Platelet count > 7500/mm^3.
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:

Confirmed pregnancy.
HCV-HIV co infection.
HBV-HCV co infection.
Uncontrolled hyper or hypothyroidism.
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
Patients on peritoneal dialysis.

Sites / Locations

Maadi armed forces hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

interventional Qurevo group

Arm Description

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 ).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03067883

First Posted

January 23, 2017

Last Updated

January 17, 2018

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03067883

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 9, 2016 (Actual)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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: The proportion of patients with a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the last dose of study drug (SVR12). To determine withdrawal rate related to side effects and /or adverse effects for patients receiving at least 1 dose of the study medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis c

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Prospective, cohort, open label trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

interventional Qurevo group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ombitasvir, Paritaprevir and Ritonavir

Other Intervention Name(s)

qurevo

Intervention Description

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 ).

Primary Outcome Measure Information:

Title

Sustained Virological Response

Description

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

Time Frame

After 12 weeks after the last dose

Secondary Outcome Measure Information:

Title

Treatment related withdrawal rate

Description

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

Time Frame

during treatment period, average duration 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Under regular HD for at least 6 months Clinically stable condition as outpatients. Treatment naïve patients with serum positive for HCV GT4 with HCV RNA > 1000 IU/ml by PCR. White blood cell count > 2500/mm^3. Platelet count > 7500/mm^3. 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: Confirmed pregnancy. HCV-HIV co infection. HBV-HCV co infection. Uncontrolled hyper or hypothyroidism. 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 Patients on peritoneal dialysis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mai Mohamed Naguib Abd Elmen'em, B.pharm

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maadi armed forces hospital

City

Cairo

State/Province

Maadi

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maadi armed forces hospital

Phone

002025265127

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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