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

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Mass General Brigham

Status and phase

Terminated
Phase 4

Conditions

Respiratory Failure
Hepatitis C

Treatments

Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks

Study type

Interventional

Funder types

Other

Identifiers

NCT03625687
2018P001697

Details and patient eligibility

About

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 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Treatment with Direct Acting Antiviral for HCV
Experimental group
Description:
8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)
Treatment:
Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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