A Study of Amphotericin B Liposome for Injection in Patients With Persistent Neutropenia and Fever
NCT ID: NCT05108545
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
93 participants
INTERVENTIONAL
2021-12-15
2023-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amphotericin B liposomes
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.
Amphotericin B liposomes
Amphotericin B liposomes for injection, 3 mg/kg, qd, IV
Interventions
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Amphotericin B liposomes
Amphotericin B liposomes for injection, 3 mg/kg, qd, IV
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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.
4. Female patients must meet one of the following conditions:
1. Menopausal patients, menopause at least 1 year;
2. Patients of childbearing age: Negative for blood/urine pregnancy test before enrollment; agree to take a guaranteed, effective contraception during the study and within 4 weeks after the study.
5. Male patients and their partners must use effective contraception throughout the study period and up to 4 weeks after leaving the study.
6. Patients fully understand and voluntarily participate in this study and sign informed consent.
Exclusion Criteria
2. Received systemic treatment of amphotericin B or amphotericin B-containing formulation within 10 days prior to enrollment.
3. Liposome used within 1 month before the signing informed consent.
4. Confirmed or clinically diagnosed invasive fungal infection or known uncontrolled bacteremia or sepsis at screening.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
6. Abnormal liver function, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥5 × the upper limit of normal (ULN), or ALT/AST ≥3 × ULN with total bilirubin ≥1.5 × ULN, or total bilirubin ≥3 × ULN.
7. Serum creatinine \> 2 × ULN.
8. Serum potassium concentration ≤3.0 mmol/L prior to the first administration, or serum potassium concentration ≤the lower limit of normal value (LLN) in patients undergoing digitalization.
9. 12-lead ECG presenting II or III degree atrioventricular block, long QT syndrome or corrected QT interval\>480 ms in the absence of a pacemaker.
10. Cardiac function grade III/IV (NYHA).
11. Tachyarrhythmia requiring intervention and a history of high-risk coronary heart disease such as unstable angina and acute coronary syndrome.
12. Human immunodeficiency virus (HIV) antibody or treponema pallidum specific antibody (TPHA) positive; active tuberculosis on CT of chest (to be determined by investigator).
13. Pregnant or lactating female.
14. A history of drug abuse (non-medical use of narcotic drugs or psychotropic substances) or drug dependence (narcotics, stimulants and psychotropic substances, etc.) within 2 years.
15. Plan to use prohibited drugs during the study period.
16. Enrolled in any other clinical trials of drugs or medical devices within 3 months prior to screening.
17. Life expectancy \< 2 months;
18. Not suitable for this study as decided by the investigator due to other reasons
18 Years
75 Years
ALL
No
Sponsors
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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HC1507-CSP-001
Identifier Type: -
Identifier Source: org_study_id