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

NCT03625687 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2018P001697
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Hepatitis C

Keywords

Lung disease; Lung Transplant; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events

  8 weeks

• Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)

  8 weeks

Study Arms (1)

Treatment with Direct Acting Antiviral for HCV

EXPERIMENTAL

8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)

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

Interventions

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

8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)

Also known as: DAA treatment, Mavyret, Epclusa

Treatment with Direct Acting Antiviral for HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or nursing (lactating) women
• HIV positivity
• Any contra-indication to lung transplantation per center protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hepatitis C; Lung Diseases

Interventions

glecaprevir and pibrentasvir; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

Study was terminated prior to completion and prior to meeting enrollment goal primarily due to lack of resources (staffing and funding) and transition of HCV-positive to HCV-negative lung transplants to standard of care. Full planned analysis was not completed due to enrollment number, however primary endpoint was assessed for all 16 subjects receiving treatment.

Results Point of Contact

• Title: Raymond Chung, MD
• Organization: Massachusetts General Hospital

Chung.Raymond@mgh.harvard.edu

6177247562

Study Officials

• Raymond T Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 10, 2018
• Study Start: February 5, 2019
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: April 25, 2023
• Results First Posted: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)