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HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant

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ClinicalTrials.gov Identifier: NCT02902120
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Husson, University of Maryland

Brief Summary:
The purpose of this study is to determine whether patients treated for chronic hepatitis C (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger immune response compared to patients treated after kidney transplant. 25 patients with chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune function will be monitored in both groups to determine their response to therapy.

Condition or disease Intervention/treatment Phase
Hepatitis C Renal Insufficiency, Chronic Disorder of Transplanted Kidney Drug: Pre-transplant Grazoprevir and Elbasvir Drug: Post-transplant Grazoprevir and Elbasvir Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Host Mechanisms Involved in Achieving SVR Using Grazoprevir and Elbasvir in Treatment of Chronic Hepatitis C in Patients With CKD Before and After Renal Transplantation
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pre-transplant
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR <50) who have not had a kidney transplant using grazoprevir and elbasvir.
Drug: Pre-transplant Grazoprevir and Elbasvir
Treatment will be started in the pre-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
Other Name: Zepatier
Experimental: Post-transplant
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR <50) who have had a kidney transplant using grazoprevir and elbasvir.
Drug: Post-transplant Grazoprevir and Elbasvir
Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
Other Name: Zepatier



Primary Outcome Measures :
  1. Change in Interferon-stimulated gene (ISG) expression [ Time Frame: This will be measured at day 0, weeks 2, 4, 8, and 12 (and week 16 for those with resistance mutations) ]
    The study will involve measuring the change in Interferon-stimulated gene (ISG) expression

  2. Change in Inducible Protein (IP)-10 levels [ Time Frame: This will be measured at day 0, weeks 2, 4, 8, and 12 (and week 16 for those with resistance mutations) ]
    The study will involve measuring the change in Inducible Protein (IP-10) levels

  3. Change in HCV-specific T cell response [ Time Frame: This will be measured at day 0, weeks 2, 4, 8, and 12 (and week 16 for those with resistance mutations) ]
    The study will involve measuring the change in HCV-specific T cell response


Secondary Outcome Measures :
  1. SVR 12 [ Time Frame: This will be measured at week 24 (or 28 for those with resistance mutations) ]
    Sustained virologic response (SVR) will be assessed by measuring the HCV viral load 12 weeks after completing treatment

  2. Safety as assessed by adverse event monitoring, including routine lab work [ Time Frame: This will be measured at day 0, weeks 2, 4, 8, 12 (and 16 if resistance mutations are present) ]
    Safety will be assessed by adverse event monitoring, including routine lab work

  3. Kidney function [ Time Frame: This will be measured at post treatment week 12 ]
    Clinical review using labs and the patient's chart will be performed for change in kidney graft function by worsening creatinine

  4. Proteinuria [ Time Frame: This will be measured at post treatment week 12 ]
    Clinical review using labs and the patient's chart will be performed for change in kidney graft function by worsening proteinuria

  5. Kidney Allograft rejection [ Time Frame: This will be measured at post treatment week 12 in the post-transplant arm ]
    Clinical review using labs and the patient's chart will be performed for documented episodes of kidney rejection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age at the time of screening
  • Have chronic kidney disease with GFR <50
  • Have Chronic HCV infection prior to transplantation with documented HCV viremia ≥ 1,000 IU/ml at screening and either documented HCV Ab positivity or HCV viremia ≥ 1,000 IU/ml at least 6 months prior to enrollment.
  • Documented genotype 1 HCV infection prior to enrollment and after their transplant in the post-transplantation cohort
  • HCV disease staging within 12 months prior to enrollment by liver biopsy, transient elastography, or biochemical testing
  • Be able to give informed consent and comply with study guidelines
  • Women of childbearing age will be required to have a negative pregnancy test at enrollment and use birth control throughout the duration of treatment.

Inclusion Criteria Specific to the Pre-transplant Arm

Patients will either be:

  • On the transplant waiting list followed by the University of Maryland's nephrology clinic or the Baltimore VA's nephrology clinic
  • On chronic hemodialysis not yet on the transplant list and followed in the University's hemodialysis center or in the University's nephrology clinic

Inclusion Criteria Specific to the Post-transplant Arm

• Patients will have undergone renal transplantation no greater than five years or less than six months prior to enrollment and will be followed in our University's nephrology and infectious disease clinic. They will all have stable renal function at the time of enrollment.

Exclusion Criteria:

  • Documented positive hepatitis B (HBV) surface antigen, and/or HBV DNA prior to enrollment
  • Any prior exposure to HCV protease inhibitor therapy
  • HIV co-infection if on a protease inhibitor based regimen
  • GFR >50 within 2 months of enrollment
  • Recent decline in renal function of 5% or greater
  • Evidence of hepatocellular carcinoma at the time of enrollment
  • Liver disease caused by an etiology other than HCV
  • F4 or decompensated cirrhotic patients
  • Child Pugh class B or C
  • AST or ALT >350 within 6 months prior to enrollment
  • Albumin < 3g/dL at the time of enrollment
  • Platelet count < 75 at the time of enrollment
  • History of clinically significant allergy or adverse event with protease inhibitors
  • Evidence of the acquisition of HCV at the time of or after transplantation
  • Pregnant or breastfeeding women
  • Cyclosporine use

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): NCT02902120


Contacts
Contact: Jennifer S Husson, MD 410-706-6973 jhusson@ihv.umaryland.edu
Contact: Ilise Marrazzo, RN,BSN,CCRP 410-706-2564 Imarrazzo@ihv.umaryland.edu

Locations
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jennifer Husson, MD    410-706-6973      
Contact: Ilise Marrazzo, RN    4107062564      
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Jennifer S Husson, MD University of Maryland School of Medicine, Institute of Human Virology

Responsible Party: Jennifer Husson, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02902120     History of Changes
Other Study ID Numbers: HP-00071069
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Hepatitis
Hepatitis C
Renal Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Kidney Diseases
Urologic Diseases
Elbasvir-grazoprevir drug combination
Antiviral Agents
Anti-Infective Agents