NCT05108545Unknown3 期
A Multicenter, Open-label, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Amphotericin B Liposome for Injection in Patients With Persistent Febrile Neutropenia
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 个研究点目标入组 93 人开始时间: 2021年12月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 93
- 主要终点
- Overall success rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Menopausal patients, menopause at least 1 year;
- •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.
- •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.
排除标准
- •History of allergy to liposomes or amphotericin B.
- •Received systemic treatment of amphotericin B or amphotericin B-containing formulation within 10 days prior to enrollment.
- •Liposome used within 1 month before the signing informed consent.
- •Confirmed or clinically diagnosed invasive fungal infection or known uncontrolled bacteremia or sepsis at screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
- •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.
- •Serum creatinine > 2 × ULN.
- •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.
- •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.
- •Cardiac function grade III/IV (NYHA).
- •Tachyarrhythmia requiring intervention and a history of high-risk coronary heart disease such as unstable angina and acute coronary syndrome.
- •Human immunodeficiency virus (HIV) antibody or treponema pallidum specific antibody (TPHA) positive; active tuberculosis on CT of chest (to be determined by investigator).
- •Pregnant or lactating female.
- •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.
- •Plan to use prohibited drugs during the study period.
- •Enrolled in any other clinical trials of drugs or medical devices within 3 months prior to screening.
- •Life expectancy < 2 months;
- •Not suitable for this study as decided by the investigator due to other reasons
研究组 & 干预措施
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.
干预措施: Amphotericin B liposomes (Drug)
结局指标
主要结局
Overall success rate
时间窗: From the initiation of the third dose to 7 days after the last dose
A successful outcome is defined as fulfilling all components of a prespecified 5-part composite endpoint.
次要结局
- Percentage of patients without discontinuation of study drug due to side effects or lack of efficacy during the treatment period(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(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(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(From the initiation of the third dose to 7 days after the last dose)
- Adverse events(From the screening period to 14 days after the last dose)
- Percentage of patients experienced fever reduction during neutropenia after initiation of treatment(From the initiation of the third dose to 7 days after 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)")
研究者
相似试验
已完成
3 期
A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)Biliary Tract CancersNCT05924880AstraZeneca116
进行中（未招募）
3 期
Study of CM310 in Adolescent Subjects With Atopic DermatisAtopic DermatitisNCT06495229Keymed Biosciences Co.Ltd180
招募中
3 期
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid TumorsLocally Advanced Solid TumorNCT06658353Jiangsu vcare pharmaceutical technology co., LTD54
已完成
3 期
Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin AnaloguesAcromegalyNCT02354508Novartis Pharmaceuticals123
已完成
3 期
A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid ArthritisRheumatoid ArthritisNCT01941095Hoffmann-La Roche100