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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphotericin B liposomes | Experimental | Patients with suspected fungal neutropenia and fever will receive amphotericin B liposome 3 mg/kg intravenously. Treatment will be continued until the ANC≥500 /mm^3 (0.5×10^9 /L) for more than 72 hrs in terms of patients without evidence of baseline fungal infection and breakthrough fungal infection; or treatment will be continued according to investigator's judgement with a duration ranging from 14 days to 12 weeks in terms of patients with evidence of baseline fungal infection and breakthrough fungal infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphotericin B liposomes | Drug | Amphotericin B liposomes for injection, 3 mg/kg, qd, IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall success rate | A successful outcome is defined as fulfilling all components of a prespecified 5-part composite endpoint. | From the initiation of the third dose to 7 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Aged 18 ~ 75 years (inclusive), no gender limitation.
Patients with neutrophilic deficiency after solid tumor chemotherapy, hematological tumor chemotherapy, hematopoietic stem cell transplantation, etc. (absolute neutrophil count (ANC) in peripheral blood <500 /mm^3 (0.5×10^9 /L) for at least 72 hours at screening).
Persistent or recurrent fever (oral temperature ≥38℃ or axillary temperature ≥37.7℃ within 24 hours prior to randomization) after at least 72 hours on broad-spectrum antibiotics, and considering fever to be associated with suspected fungal infection.
Female patients must meet one of the following conditions:
Male patients and their partners must use effective contraception throughout the study period and up to 4 weeks after leaving the study.
Patients fully understand and voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuefang Xia | Contact | +86-010-63932012 | xiaxuefang@mail.ecspc.com |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D005334 | Fever |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Percentage of patients survived |
| 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 | 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 | 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) | From the initiation of the third dose to 7 days after the last dose |
| Adverse events | Adverse events | 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)" | Pre-dose and multiple timepoints up to 4 hours of the last dose |
| Pharmacokinetic profile of amphotericin B | 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)" |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |