Clinical Trial

Study on the Pharmacokinetic Characteristics of Liposomal Amphotericin B in Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy

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Summary
The goal of this prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and integrate the findings with efficacy and safety outcomes. The main questions it aims to answer is: Clarifying the correlation between the concentration, efficacy, and safety of different forms of liposomal amphotericin B in a special population, explore the changes in drug concentration mediated by plasma exchange, elucidate the mechanism of individual differences in efficacy and the optimal dosage, in order to provide a basis for personalized treatment of liposomal amphotericin B. The study plans to collect pharmacokinetic samples from 10 adult (aged ≥ 18 years) severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Trial Details
NCT Number NCT07532850
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Invasive Fungal Infections
Enrollment 10 participants
Start Date 2026-03-30
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-16