EUCTR2014-004183-38-Outside-EU/EEA进行中（未招募）不适用
An open, intravenous multiple dose, multi-centre study to investigate the pharmacokinetics, safety and toleration of Voriconazole in children aged 2-12 years who require treatment for the prevention of systemic fungal infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer, Inc.
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Children (both male and female) aged from 2 to <12 years who required treatment for the prevention of systemic fungal infection.
- •2. Children who were expected to develop neutropenia lasting for more than 10 days following chemotherapy for one of the following conditions:
- •a. leukaemia
- •b. lymphoma
- •c. aplastic anaemia
- •d. as the preparative regimen for bone marrow transplantation
- •3. Subjects who were anticipated to live for more than three months.
- •4. Females of childbearing potential must have had a negative pregnancy test at entry.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 28
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who were receiving and could not discontinue the following drugs at least 24 hours prior to study start:
- •Terfenadine and cisapride (due to the possibility of QTc prolongation with these drugs)
- •Omeprazole (an inhibitor of CYP2C19) which is known to increase plasma voriconazole levels.
- •Subjects who had received the following drugs within 14 days prior to study entry:
- •Rifampicin, rifabutin, carbamazepine, phenytoin, nevirapine and barbiturates as these are inducers of hepatic enzymes and may result in undetectable levels of voriconazole.
- •2. Subjects who had received astemizole within the previous 60 days.
- •3. Subjects with any clinically significant abnormality following review of screening laboratory data other than that associated with their underlying disease. Aspartate transaminase (AST) and alanine transaminase (ALT) had to be <5 * upper limit of normal.
- •4. Subjects who were taking or were likely to receive any investigational drug except: those used for the treatment of child’s cancer, antiretroviral agents and drugs used for treatment of any acquired immune deficiency syndrome (AIDS) defining opportunistic infections, all of which were allowed.
- •5. Subjects with a history of hypersensitivity to or severe intolerance of azole antifungal agents.
- •6. Subjects who had already been entered into this protocol once.
- •7. Subjects with moderate and severe renal impairment (
- •i.e. calculated creatinine clearance <30 millilitre per minute (ml/min). If creatinine clearance was reduced to <30 ml/min at any time during the study, the subject had to be discontinued from the study. Creatinine clearance was calculated using the equation
- •Creatinine Clearance (ml/min) = 0.55*height (cm)/serum creatinine (mg/dL)
- •8. Subjects with a medical history or current evidence of cardiac arrhythmia.
- •9 Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment.
研究者
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