Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

November 1, 2019 updated by: Institute of Liver and Biliary Sciences, India

A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy

All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with Hepatitis C infection attending nephrology and Hepatology OPD (Out Patient Department) or getting outpatient dialysis at the dialysis unit of Institute of Liver and Biliary Sciences.

Description

Inclusion Criteria:

  1. Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
  2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

  1. Age less than 18 years
  2. Confirmed pregnancy
  3. HCV-HIV Co infection
  4. HBV-HCV co infection

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

Cohorts and Interventions

Group / Cohort
advanced chronic kidney disease
Subjects on dialysis with GFR (Glomerular Filtration Rate) > 30
Renal replacement therapy.
Subjects who are not on dialysis with GFR (Glomerular Filtration Rate) < 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
number of adverse Events in both groups
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr Suman Lata Nayak, DM, Institute of Liver and Biliary Sciences

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

September 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

September 26, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (ESTIMATE)

September 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-HCKD/001/SOFO/2015

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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