Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver… (NCT07725874) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients
60 participantsStarted 2026-08-08
Plain-language summary
Invasive mold diseases (IMD) carry extremely high mortality rates in liver transplant recipients (aspergillosis prevalence \~1.8%, mortality 60%-90%; mucormycosis prevalence \~2%, mortality 38%-95%). Guidelines emphasize early antifungal therapy: liposomal amphotericin B (L-AmB) is the first-line choice in liver insufficiency; voriconazole remains the gold standard for aspergillosis (but ineffective against mucormycosis), yet its use is limited by significant drug-drug interactions-requiring a 50%-60% dose reduction of calcineurin inhibitors and contraindicated with sirolimus-thereby increasing the risk of graft rejection. Currently, no head-to-head clinical trials compare voriconazole and L-AmB in liver transplant recipients with IMD. Therefore, a prospective real-world study is planned to generate robust data to support updates to international or Chinese guidelines.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients aged ≥12 years. Liver transplant recipients. Proven or probable invasive mold disease (IMD) according to the 2020 EORTC/MSGERC criteria.
Have received at least one dose of liposomal amphotericin B (AmBisome) or voriconazole.
Exclusion Criteria:
History of invasive mold disease previously treated with amphotericin B for more than 5 days.
Documented hypersensitivity or allergy to amphotericin B formulations. Sequential Organ Failure Assessment (SOFA) score \>15. Expected survival \<72 hours. Pregnant or breastfeeding. Patients who, in the investigator's judgment, are unable to complete the study treatment or follow the study protocol.
Recipients of combined organ transplantation or multivisceral transplantation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint of this study is the safety profile of liposomal amphotericin B (AmBisome) in liver transplant recipients with invasive mold disease
Timeframe: The comprehensive assessment for the primary safety endpoint will be performed at Week 6 (±7 days) after the initiation of antifungal therapy. If a patient prematurely discontinues treatment for any reason, the assessment time point will be at the time o