Evaluation of Treatment of Chronic HCV Patients in Chronic Kidney Disease Versus End Stage Renal Disease Patients

May 18, 2018 updated by: Mohamed A Mekky, Assiut University

Evaluation of the Clinical Effects of Ombitasvir/Paritaprevir/Ritonavir Regimen in the Treatment of Chronic HCV Patients in CKD Versus ESRD Patients in Assiut University Hospital

  1. To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .
  2. Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C virus (HCV) is a leading cause of liver disease worldwide, as 130-170 million individuals are chronically infected and 350,000 patients die every year from HCV infection. The HCV prevalence varies widely among countries being highest in several African and Eastern Mediterranean countries. So public health authorities should recognise the importance of HCV and make resources available for the implementation of effective primary prevention, screening and management policies .

The hepatitis C virus (HCV) genotype is an important predictor of disease progression and treatment response. Genotype 1b has a worldwide distribution and is often found to be the most common genotype. HCV-genotype 4 causes approximately 20% of the 180 million cases of chronic hepatitis C in the world, is predominant in the Middle East and Northern Africa, and has recently spread to Southern Europe. Genotype 4 accounts for more than 90% of the reported cases from Egypt, a country with a massive HCV-related disease burden.

The prevalence of anti-hepatitis C virus Ab (anti-HCV) positivity among dialysis patients varies across countries, ranging from 3 to 75%; unfortunately, Egypt is considered one of the countries with the highest prevalence despite the existence of guidelines for a comprehensive infection control program.

In Egypt In the 15-59-year age groups, the prevalence of HCV antibody was found to be 10.0% and that of HCV RNA to be 7.0%. Approximately, 3.7 million persons have chronic HCV infection in the age group 15-59 in 2015.

In the treatment of chronic HCV in renal impairment For patients with mild to moderate renal impairment (CrCl 30 mL/min-80 mL/min), no dosage adjustment is required when using fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) .

Abbvie's 2D regimen (paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir(25mg)) was recently approved with specific indication for genotype 4 treatment naïve and experienced patients without cirrhosis achieved an sustained viral response rate of 100% following 12 weeks of 2D regimen with RBV, 2D can be used without RBV but may have slightly lower SVR (91% vs 100%). Currently, there is no FDA indication for 2D regimen use in patients with cirrhosis.

. Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) .

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patients aged from18- 60 years.
  2. Chronic HCV infection with Plasma HCV RNA greater than 15,000 IU/mL
  3. Treatment naïve.
  4. compensated liver cirrhosis.
  5. Absence of coinfection with HBV or HIV.

Exclusion Criteria:

  1. Patients with hepatitis B virus or HIV.
  2. prior antiviral therapy.
  3. Haemoglobin level less than 10mg/dl.
  4. Decompensated liver disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ombitasvir (25 mg ), Paritaprevir (150 mg ) once daily
Ombitasvir (25 mg once daily), Paritaprevir (150 mg once daily), Ritonavir (100 mg once daily)Ribavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) given to 50 chronic HCV infected patients with renal impairment for 12 week
Drug: Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram
To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in ch HCV infected patients in those with CKD vs ESRD 2- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD vs ESRD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the sustained viral response of Ombitasvir/Paritaprevir/Ritonavir regimen in the treatment of Chronic HCV patients in CKD versus ESRD patients in Assiut University Hospital
Time Frame: 6 months
pathologic complete remission for HCV after tretment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Hala Elsherif, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV in renal impairment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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