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

Phase 4

Terminated

• Conditions: Respiratory Failure; Hepatitis C
• Interventions: Drug: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks

• Registration Number: NCT03625687
• Lead Sponsor: 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 8 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 Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Study Start: 2019-02-05
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Results First Submitted: 2023-02-02
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Results First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Direct Acting Antiviral for HCV	Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks	8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)

Primary Outcome Measures

Name	Time	Method
Undetectable Blood HCV RNA Level	12 weeks post last dose of treatment with DAA	Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	8 weeks	Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient
Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)	8 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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States