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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03625687
• Other study ID #: 2018P001697
• Status: Terminated
• Phase: Phase 4
• Start date: February 5, 2019
• Est. completion date: April 4, 2022

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable Blood HCV RNA Level	Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.	12 weeks post last dose of treatment with DAA
Secondary	Number of Participants With Treatment Emergent Adverse Events	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	8 weeks
Secondary	Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)	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	8 weeks