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Trial record 95 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Hepatitis C Positive Donor Into Hepatitis C Negative Recipients

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ClinicalTrials.gov Identifier: NCT03702218
Recruitment Status : Withdrawn (never started)
First Posted : October 11, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
David Bruno, University of Maryland, College Park

Brief Summary:

Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys and livers available for transplantation and the number of patients on the transplant waiting list. New donor pools are needed to satisfy the lack of available donor organs, along with expanded criteria for the existing donor pools.

A new standard of care now exists at most local and regional transplant centers. This new standard of care is based on the use of multiple direct-acting antiviral agents (DAAs) for treatment of hepatitis C virus (HCV) that have been approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C and are associated with high HCV cure rates and minimal side effect profiles. The efficacy and tolerability of these medications has allowed the expansion of the available donor pool by making HCV antibody positive non viremic organs and HCV-viremic organs (when HCV is detectable in the blood) available to HCV-naive recipients on the organ transplantation waiting list. Expansion of this donor pool may decrease time on the waiting list and improve quality of life and survival while waiting for organ transplantation.

Study Aim:

We propose a clinical protocol to utilize solid organs from exposed and/or HCV-viremic organ donors for transplantation into HCV negative recipients.

The primary purpose of the clinical protocol is to:

Collect prospective standard of care laboratory data on the results of these interventions


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Direct Acting Antivirals Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label Pilot Study to Determine the Safety and Efficacy of Hepatitis C Uninfected Recipients of Renal and Liver Transplants From a Currently Infected or Previously Infected Hepatitis C Donor
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hep C Ab + NAT - Donor to Naïve Recipient

HCV Ab and HCV NAT testing at 3 days, week 1, week 2 and monthly for 3 months, at 6 months and 1 year. In approximately 16% of the patients, active hepatis C infection will ensue. For these patients, treatment is as follows.

Liver Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
  • Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
  • Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30

Kidney Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
  • Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30
Drug: Direct Acting Antivirals

Patients who are given organ transplants from donors that are Ab positive and NAT negative or Ab positive and NAT positive for Hepatitis C will be treated with direct acting antivirals after transplant if they become NAT+ for hepatitis C.

Interventions as follows.

Liver Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
  • Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
  • Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30

Kidney Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
  • Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30

Experimental: Hep C Ab+ NAT+ Donor to Naïve Recipient

HCV RNA levels, liver biochemistries, and renal function will be measured 3 days after transplant. HCV Genotype will be determined after HCV RNA is >1,000 IU/mL. HCV RNA levels will be measured weekly after transplant until HCV treatment is initiated.

Liver Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
  • Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
  • Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30

Kidney Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
  • Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30
Drug: Direct Acting Antivirals

Patients who are given organ transplants from donors that are Ab positive and NAT negative or Ab positive and NAT positive for Hepatitis C will be treated with direct acting antivirals after transplant if they become NAT+ for hepatitis C.

Interventions as follows.

Liver Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
  • Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
  • Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30

Kidney Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
  • Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30

Active Comparator: Hep C Ab- NAT - Donor to Naïve Recipient
Current standard of care for donor recipient infectious disease matching. No treatment necessary
Drug: Direct Acting Antivirals

Patients who are given organ transplants from donors that are Ab positive and NAT negative or Ab positive and NAT positive for Hepatitis C will be treated with direct acting antivirals after transplant if they become NAT+ for hepatitis C.

Interventions as follows.

Liver Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
  • Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
  • Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30

Kidney Transplant:

• Combinations of choice:

  • Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
  • Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30




Primary Outcome Measures :
  1. SVR after receiving an organ from a donor previously exposed to Hepatitis C after treatment direct-acting antiviral drugs. [ Time Frame: 12 months ]
    To improve access to transplantation with use of HCV-non viremic and HCV-viremic organs in HCV negative patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • RECIPIENT INCLUSION CRITERIA

    • Patients undergoing solid organ transplantation, including liver, kidney, and simultaneous liver-kidney who are not chronically infected with HCV
    • No evident contraindication for organ transplantation
    • HCV RNA negative (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)
    • Age 18-75 years at the time of transplantation
    • Signed Informed Consent Form
    • No identified living organ donor
    • Able to travel to the University of Maryland for routine post-transplant and HCV follow-up visits
    • Men and women must agree to use at least one barrier method to prevent any secretion exchange
    • No active illicit drug use

DONOR INCLUSION CRITERIA

• Qualitative HCV nucleic acid test (NAT) positive and/or Hepatitis C antibody positive HCV donors offered to the University of Maryland.

Exclusion Criteria:

RECIPIENT EXCLUSION CRITERIA

  • History of prior solid organ transplantation
  • HIV infection
  • HBV surface antigen or DNA positive. Organs from HCV positive donors who are also Hepatitis B core antibody positive (hepatitis B surface antigen negative) can be used. These patients will however need to undergo prophylaxis for HBV according to their respective organ specific criteria and during treatment for hepatitis C due to the increased risk of reactivation of hepatitis B with DAA therapy
  • Waitlisted for a multi-organ transplant (with the exception of simultaneous liver-kidney transplant)
  • HCV RNA positive (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)
  • Prior direct-acting antiviral (DAA) treatment for HCV. Patients previously treated with interferon-based regimens may be included.

DONOR EXCLUSION CRITERIA

  • Every donor that is considered unsuitable by the transplant surgeon for any reason.
  • Hepatocellular carcinoma
  • HIV infection
  • Use of HCV positive livers to be determined according to current existing criteria

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): NCT03702218


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park

Publications:
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Responsible Party: David Bruno, Assistant Professor, Surgery, Transplant, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03702218     History of Changes
Other Study ID Numbers: HP-00083009
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be published in peer reviewed journals.
Supporting Materials: Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Bruno, University of Maryland, College Park:
Transplantation
Hepatitis C
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Sofosbuvir
Velpatasvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents