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Hepatitis B Immune Globulin + Antiviral Prophylaxis for Lung Transplant Candidates (INHIBITOR Trial)

Phase 2

Recruiting

Led By Andrew M Courtwright, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-menopausal women must agree to use birth control in accordance with the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) following transplant

Age 18-70 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

INHIBITOR Trial Summary

This trial is testing if HBV-infected lungs can be safely transplanted into patients who have been vaccinated against HBV and are taking medication to prevent HBV infection.

Who is the study for?

This trial is for adults aged 18-70 who need a lung transplant, have been vaccinated against hepatitis B with sufficient immunity, and can travel to the University of Pennsylvania for follow-ups. They must use birth control post-transplant. Those with chronic liver disease (other than NAFLD), significant fibrosis, inadequate drug coverage, or certain medical conditions are excluded.Check my eligibility

What is being tested?

The study tests if it's safe and effective to transplant lungs from donors positive for hepatitis B virus into patients vaccinated against HBV. These patients will receive Hepatitis B Immune Globulin and antiviral drugs like entecavir or tenofovir after the surgery.See study design

What are the potential side effects?

Possible side effects include allergic reactions to immune globulins or antiviral medications, which could range from mild skin reactions to severe anaphylaxis. Antivirals may also cause kidney problems, lactic acidosis, bone thinning or pain.

INHIBITOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to follow specific birth control guidelines after my transplant.

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I am between 18 and 70 years old.

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I agree to use birth control or remain abstinent after my transplant due to HBV risk.

INHIBITOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of HBV viremia

Rate of acute HBV-associated hepatitis

Rate of persistent HBV surface antigen positivity

+1 more

Secondary outcome measures

One year graft survival

One year patient survival

INHIBITOR Trial Design

1Treatment groups

Experimental Treatment

Group I: Recipient of Hepatitis B NAT+ DonorExperimental Treatment1 Intervention

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)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,199 Total Patients Enrolled

3 Trials studying Hepatitis B

5,741 Patients Enrolled for Hepatitis B

Andrew M Courtwright, MD, PhDPrincipal InvestigatorHospital of University of Pennsyvlania

Media Library

Recipient of Hepatitis B NAT+ Donor Clinical Trial Eligibility Overview. Trial Name: NCT05404919 — Phase 2

Hepatitis B Research Study Groups: Recipient of Hepatitis B NAT+ Donor

Hepatitis B Clinical Trial 2023: Recipient of Hepatitis B NAT+ Donor Highlights & Side Effects. Trial Name: NCT05404919 — Phase 2

Recipient of Hepatitis B NAT+ Donor 2023 Treatment Timeline for Medical Study. Trial Name: NCT05404919 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the end goal of this research?

"The primary outcome being evaluated in this trial, which will take place over the course of a year, is Efficacy objective 1. Additionally, the secondary outcomes include Additional outcomes 1, One year patient survival, and One year graft survival."

Answered by AI

Is there a known cure rate for this treatment?

"This is a Phase 2 trial, which means that while there is some evidence that the treatment is safe, there is no data yet to support that it is effective. Our team at Power gave it a score of 2."

Answered by AI

Does this clinical trial have an age limit? If so, what is the oldest age group that is being accepted?

"The age limit for this trial is 70 years old. All patients that are above 18 years old are eligible."

Answered by AI

For which patients is this study appropriate?

"This trial is looking for 10 participants with hepatitis b who meet the following criteria: 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 ≥"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates

Andrew M Courtwright 2022. "Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05404919.

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