This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever.
This is a multicenter, open-label, single-arm, phase III study to evaluate the safety and efficacy of Amphotericin B liposomes in patients with persistent neutropenia and fever. About 93 patients will be recruited in this study. The patients will receive Amphotericin B liposomes intravenous infusion at a dose of 3 mg/kg over 2 hours once daily (qd) for a maximum of 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Amphotericin B liposomes for injection, 3 mg/kg, qd, IV
Overall success rate
A successful outcome is defined as fulfilling all components of a prespecified 5-part composite endpoint.
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients without new fungal infections from the initiation of the first dose to 7 days after the last dose
Percentage of patients without new fungal infections
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients survived from the initiation of the first dose to 7 days after the last dose
Percentage of patients survived
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients without discontinuation of study drug due to side effects or lack of efficacy during the treatment period
Percentage of patients without discontinuation of study drug due to side effects or lack of efficacy
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients experienced fever reduction during neutropenia after initiation of treatment
Percentage of patients experienced fever reduction during neutropenia
Time frame: From the initiation of the third dose to 7 days after the last dose
Percentage of patients with complete or partial remission of confirmed or clinically diagnosed IFD (baseline fungal infection) at the end of treatment
Percentage of patients with complete or partial remission of confirmed or clinically diagnosed Invasive fungal disease (baseline fungal infection)
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Time frame: From the initiation of the third dose to 7 days after the last dose
Adverse events
Adverse events
Time frame: From the screening period to 14 days after the last dose
Pharmacokinetic profile of amphotericin B
Pharmacokinetic profile of amphotericin B, Such as "Peak Plasma Concentration (Cmax)"
Time frame: Pre-dose and multiple timepoints up to 4 hours of the last dose
Pharmacokinetic profile of amphotericin B
Time frame: Pre-dose and multiple timepoints up to 4 hours of the last dosePharmacokinetic profile of amphotericin B, Such as "Area under the plasma concentration versus time curve (AUC)"