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Safety and Efficacy of Liposomal Amphotericin B for Patients With Invasive Mold Diseases in Liver Transplant Recipients

NCT07725874 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Invasive Mold Diseases

Interventions

DRUG

AmBisome (Amphotericin B) Liposome

This intervention is applied prospectively to the AmBisome group (target enrollment: 60 patients). The study does not mandate a fixed dose or fixed course length; rather, it reflects real-world clinical practice. All safety parameters (hepatotoxicity, nephrotoxicity, hypokalemia, cardiotoxicity, infusion reactions, tacrolimus dose/concentration changes, and serious adverse events) are longitudinally monitored during the intervention period.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-08
Primary Completion
2028-05-15
Completion
2028-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725874 on ClinicalTrials.gov