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Trial record 69 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

A Prospective Cohort Study to Improve HCV Care in Dialysis Patients (MATCH-D)

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ClinicalTrials.gov Identifier: NCT03791814
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Davita Clinical Research
Information provided by (Responsible Party):
Eyob Feyssa, Albert Einstein Healthcare Network

Brief Summary:

Hepatitis C virus (HCV) infects an estimated 185 million individuals worldwide and 3.4 million to 4.4 million people in the United States. Approximately 80% of acutely infected HCV patients progress to chronic infection, 20% of whom develop cirrhosis within 25 years, with 25% of patients with cirrhosis developing hepatocellular carcinoma and/or decompensated liver disease. Hepatitis C virus is the primary cause of liver transplantation in the United States.

There are 6 known genotypes of HCV. The most common genotypes in the United States are genotype 1 (subtypes 1a and 1b), 2, and 3, which together comprise 97% of all infections.

In chronic kidney disease (CKD) patients, the prevalence of HCV infection is higher than in the general population. Patients with impaired kidney function have limited therapeutic options. The US Food and Drug Administration (FDA) recently approved Elbasvir/Grazopevir for treatment of genotype 1 and 4 infection in CKD patients including those on hemodialysis.

At our institution, the Multidisciplinary Approach to the Treatment of Chronic Hepatitis C (MATCH) Initiative is a program which was first implemented to increase screening, diagnosis and treatment of HCV by actively incorporating primary care providers (PCP) at every step of the HCV care process. Following implementation of MATCH, early data indicates, marked increase in screening high risk and baby-boomer cohorts, as well as safe and effective treatment of HCV cases at the primary provider setting. The initiative proved that active participation of PCPs in the care of HCV reduced the treatment lag by 71% compared to traditional care of referring HCV cases to specialized care (Gastroenterology or Hepatology) while keeping similar SVR. We intend to expand the program to improve quality of care for HCV patients in dialysis center. We propose active involvement of dialysis clinical staff including nephrologist, to increase HCV screening rate, promote timely diagnosis and treatment of CHC in patient with end-stage renal disease.

This study is being conducted to evaluate real-world effectiveness of HCV DAA therapy in CHC hemodialysis patients when the DAA-treatment is managed and monitored by the clinical staff of hemodialysis center.

Primary objective: To determine sustained virologic response (SVR) rates attained with open-label Zepatier administered through hemodialysis center under the supervision of a nephrologist in chronic hepatitis C infected (CHC) patient currently on hemodialysis.

Secondary objective:

  1. To estimate prevalence of HCV infection, severity of fibrosis (using non-invasive measures), and HCV detection rate in patients with End stage renal disease on hemodialysis.
  2. To calculate the average treatment-lag time (time from HCV diagnosis to submission of treatment approval).

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Zepatier Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Cohort Study to Improve HCV Care Using Multidisciplinary Approach to the Treatment of Chronic Hepatitis C in Dialysis Patients: The MATCH-D Study
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zepatier treatment
Open-label Zepatier (grazoprevir 100 mg and elbasvir 50 mg) will be administered in this study. Daily treatment of Zepatier for a 12-week duration will be administered.
Drug: Zepatier
Patients screened as HCV positive will receive Zepatier for 12 weeks.




Primary Outcome Measures :
  1. HCV treatment-lag time [ Time Frame: 12 weeks ]
    To determine the average treatment-lag time (time from HCV diagnosis to submission of treatment approval) of HCV treatment delivered through hemodialysis centers by nephrologists compared to standard of care via traditional gastroenterology or hepatology centers.


Secondary Outcome Measures :
  1. Prevalence rates [ Time Frame: 12 weeks ]
    To estimate prevalence of HCV infection, severity of fibrosis (using non-invasive measures), and HCV detection rate in patients with End stage renal disease on hemodialysis.

  2. Sustained virologic response (SVR) rates [ Time Frame: 6 months ]
    2. To determine sustained virologic response (SVR) rates of open-label Zepatier in chronic hepatitis C infected (CHC) patient who are currently on hemodialysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years of age or older on day of signing the informed consent form.
  • Be on long term hemodialysis at any of the selected 4 collaborative hemodialysis centers
  • Have positive anti-HCV antibody titers and detectable HCV RNA level before or after the initiation of MATCH-D.
  • HCV genotype 1 and 4
  • Have an HCV treatment status that is one of the following:

    1. Treatment naïve: Naive to all anti-HCV treatment
    2. Prior IFN or PEG-IFN + Ribavirin Treatment failures: Null responders, Partial responders, Relapsers
    3. P/R Intolerant: Subjects were intolerant to a prior IFN or PEG-IFN

      • Ribavirin regimen, Subjects discontinued treatment prematurely and were therefore unable to complete a full course of therapy because of drug-related toxicity.

Exclusion Criteria:

  • Has evidence of decompensated chronic liver disease such as presence of or history of - ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease
  • Have Child-Pugh B or C cirrhosis (these patients will need to be referred to a hepatologist for HCV therapy)
  • Have a likelihood of receiving a renal transplant or liver transplant during the study treatment period.
  • Have hepatocellular carcinoma
  • Have other liver disease (which require HCV therapy to be delivered under the supervision of a hepatologist)
  • A patient with a life expectancy less than 12 months
  • Current untreated chronic hepatitis B infection HBsAg+ patients are excluded. Note: Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and will be monitored while on DAA therapy and medically managed as considered appropriate by the PI.
  • Have HIV and currently not under Antiretroviral Therapy (ART)
  • Pregnant or nursing (lactating) women
  • Albumin below 3g/dL
  • Platelet count below 75,000
  • Unable to comply with research study visits
  • Poor venous access not allowing screening laboratory collection
  • Have any condition that the investigator considers a contraindication to study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791814


Contacts
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Contact: Eyob Feyssa, MD 215-456-8543 feyssae@einstein.edu
Contact: Tony Durkee, PhD 2154567466 durkeeto@einstein.edu

Sponsors and Collaborators
Albert Einstein Healthcare Network
Merck Sharp & Dohme Corp.
Davita Clinical Research
Investigators
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Principal Investigator: Eyob Feyssa, MD Albert Einstein Healthcare Network
Study Director: Manisha Verma, MBBS, MPH Albert Einstein Healthcare Network

Publications:
Sandhu N, Mulki R, Tosounian S, Wheeler D, Feyssa E, Baumann A. Multidisciplinary Approach to the Treatment of Chronic Hepatitis C: The MATCH Initiative AASLD Abstract presentation. 2017.
Merck Sharp & Dohme Corporation (January 2016). ZEPATIER™ tablets. Highlights of Prescribing Information. 2016.
Merck Sharp & Dohme Corporation (July 2015). Elbasvir (MK-8742). Investigator's Brochure (8th Ed.).2015.
Merck Sharp & Dohme Corporation (July 2015). Grazoprevir (MK-5172). Investigator's Brochure (10th Ed.). 2015.

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Responsible Party: Eyob Feyssa, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT03791814     History of Changes
Other Study ID Numbers: MATCH-D study
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eyob Feyssa, Albert Einstein Healthcare Network:
HCV treatment
Zepatier
Dialysis patients
Additional relevant MeSH terms:
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Elbasvir-grazoprevir drug combination
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents