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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

Tracking Information
First Submitted Date  ICMJE July 30, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE February 5, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03625687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Official Title  ICMJE Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Respiratory Failure
  • Hepatitis C
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Treatment with Direct Acting Antiviral for HCV
12 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)
Intervention: Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 12 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Raymond T Chung, MD 6177247562 RChung@partners.org
Contact: Jenna L Gustafson, MS 6177243836 jlgustafson@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625687
Other Study ID Numbers  ICMJE 2018P001697
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Raymond T. Chung, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP