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Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

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ClinicalTrials.gov Identifier: NCT03625687
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief Summary:
This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Condition or disease Intervention/treatment Phase
Respiratory Failure Hepatitis C Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 12 weeks Phase 4

Detailed Description:
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Direct Acting Antiviral for HCV
12 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)
Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 12 weeks
12 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
Other Names:
  • DAA treatment
  • Mavyret
  • Epclusa




Primary Outcome Measures :
  1. Undetectable blood HCV RNA level [ Time Frame: 12 weeks post treatment ]
    Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.


Secondary Outcome Measures :
  1. Safety (based on number of adverse events and clinically significant lab values) of DAA therapy in patients undergoing lung transplantation [ Time Frame: 12 weeks ]
    Safety of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results as compared to baseline/pretreatment values per patient.

  2. Tolerability (based on number of adverse events and clinically significant laboratory values) [ Time Frame: 12 weeks ]
    Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results



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

Inclusion Criteria:

  • Met MGH transplant center criteria, listed for lung transplant
  • Able to sign informed consent

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • HIV positivity
  • Any contra-indication to lung transplantation per center protocol
  • For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
  • For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.

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): NCT03625687


Contacts
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Contact: Raymond T Chung, MD 6177247562 RChung@partners.org
Contact: Jenna L Gustafson, MS 6177243836 jlgustafson@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jenna L Gustafson, MSc    617-724-3836    JLGustafson@partners.org   
Principal Investigator: Raymond T Chung, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital

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Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03625687     History of Changes
Other Study ID Numbers: 2018P001697
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anticipate to share coded data with collaborators
Supporting Materials: Study Protocol
Time Frame: Anticipate data would be available to share within 6 months after the final patient completes the study.
Access Criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.

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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.: No

Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
Lung disease
Lung Transplant
HCV
Hepatitis C

Additional relevant MeSH terms:
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Hepatitis
Hepatitis C
Respiratory Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Respiration Disorders
Respiratory Tract Diseases
Antiviral Agents
Sofosbuvir-velpatasvir drug combination
Sofosbuvir
Anti-Infective Agents