NCT05404919

Brief Summary

The objective of this study is to determine the safety and efficacy of transplanting lungs from hepatitis B virus (HBV) nucleic acid test positive (NAT+) donors into HBV vaccinated HBV surface antibody positive (sAb+) lung transplant candidates, who will then be treated with Hepatitis B Immune Globulin (HBIG) and entecavir, tenofovir disoproxil, or tenofovir alafenamide.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

May 7, 2022

Last Update Submit

August 2, 2024

Conditions

Lung TransplantHepatitis B

Outcome Measures

Primary Outcomes (4)

  • Rate of HBV viremia

    HBV viremia rate in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.

    1 year

  • Time to undetectable HV DNA

    Time to undetectable HBV DNA rate in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.

    1 year

  • Rate of acute HBV-associated hepatitis

    Rates of acute HBV-associated hepatitis in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.

    1 year

  • Rate of persistent HBV surface antigen positivity

    Rates of persistent HBV surface antigen (HBsAg) positivity at one year in HBV vaccinated patients who receive a lung transplant from a HBV NAT+ donor.

    1 year

Secondary Outcomes (2)

  • One year patient survival

    1 year

  • One year graft survival

    1 year

Study Arms (1)

Recipient of Hepatitis B NAT+ Donor

OTHER

All subjects will then be treated with Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide (choice of specific drug to be based on long-term cost, clinical response, and renal function)

Drug: Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamide

Interventions

Hepatitis B Immune Globulin and entecavir, tenofovir disoproxil, or tenofovir alafenamideDRUG

Anti-hepatitis B medications

Recipient of Hepatitis B NAT+ Donor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Able to provide informed consent
  • Willing and able to travel to the University of Pennsylvania for routine post-transplant study visits
  • Pre-menopausal women must agree to use birth control in accordance with the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) following transplant
  • Both men and women must agree to use at least one barrier method of birth control or remain abstinent following transplant due to risk of HBV transmission
  • Appropriate HBV vaccine pre-transplant response, defined as HBV sAb ≥12.00 mIU/mL

You may not qualify if:

  • Donor characteristics:
  • Donation after circulatory death donor
  • Hepatitis C Virus (HCV) NAT+
  • PaO2/FiO2 \<300 on FiO2 = 100% and PEEP=5
  • Age \>55 years
  • Smoking history \>20 pack years
  • Transplant candidate characteristics:
  • Age \>70 years
  • Any chronic liver disease (excluding non-alcoholic fatty liver disease (NAFLD)) associated with persistently elevated liver enzymes
  • Significant fibrosis (≥F2 on Fibroscan or Fib4 ≥1.67 (for patients unable to complete Fibroscan and without liver disease risk factors))
  • Inadequate insurance coverage of entecavir, tenofovir disoproxil, or tenofovir alafenamide
  • Retransplant candidate
  • Current use of extracorporeal membrane oxygenation (ECMO) or mechanical ventilation as a bridge to lung transplantation
  • HIV infection
  • Chronic kidney disease with estimated glomerular filtrate rate less than 50 ml/min/1.73 m2
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

hepatitis B hyperimmune globulinentecavirTenofovirtenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Andrew M Courtwright, MD, PhD

    Hospital of University of Pennsyvlania

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

May 7, 2022

First Posted

June 3, 2022

Study Start

September 6, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)