CTRI/2012/01/002352已完成3 期
Open Label Study of Isavuconazole in the Treatment of Patients with Aspergillosis and Renal Impairment or of Patients with Invasive Fungal Disease Caused by Rare Molds,Yeasts or Dimorphic Fungi.
Astellas Pharma Global Development Inc APGD0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female patients aged >= 18 years at the time of signing the informed consent.
- •Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons:
- •- Postmenopausal for at least 1 year
- •- Post-hysterectomy and/or post-bilateral ovariectomy
- •- If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hCG) pregnancy test at screening and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.
- •Patients who fall into one of the following 5 subgroups:
- •a) Patients with proven, probable or possible invasive aspergillosis who have renal impairment, defined as calculated [Table 10] creatinine clearance (CLcr) < 50 ml/min at
- •enrollment who require primary therapy.
- •NB: Patients fulfilling the criteria for â??possibleâ?? invasive aspergillosis who also have renal impairment will be eligible for enrollment; however, diagnostic tests to confirm the invasive aspergillosis as â??probableâ?? or â??provenâ?? by culture, histology/cytology or galactomannan (GM) antigen must be completed within 7 days after the first administration of study medication.
- •b) Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not who require primary therapy for their IFD at the time of enrollment as defined in the body of the protocol.
- •c) Patients who have zygomycosis and require primary therapy are eligible for enrollment.
- •Patients from the double-blinded WSA-CS-004 who had cultures positive for zygomycosis
- •may discontinue blinded study drug and instead roll-over into WSA-CS-003 to complete primary therapy.
- •d) Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) who are refractory to current treatment
- •defined as:
- •clear documentation of progression of disease
- •NB radiological progression only in association with WBC recovery is not
- •failure to improve clinically despite currently receiving at least 7 days of standard
- •antifungal regimen
- •Prior to enrolling patients that fall into this category, please contact the Medical Monitor for
- •e) Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive
- •probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens
- •other than Aspergillus fumigatus or Candida species) who are intolerant to current
- •treatment defined as:
- •doubling of serum creatinine value to higher than the upper limit of normal
- •(ULN) within 48 hours
- •serum creatinine > 2.0 mg/ml and current treatment with polyene or IV
- •voriconazole
- •other significant drug-related adverse reaction(s) to the current antifungal agent,
- •resulting in discontinuation of the treatment, e.g. persistence of visu
排除标准
- •Women who are pregnant or breastfeeding.
- •2. Known history of allergy, hypersensitivity, or any serious reaction to the azole class of
- •antifungals or to any component of the study medication.
- •3. Patients at high risk for QT/QTc prolongation such as:
- •- Baseline prolongation of QTcF 500 msec
- •- Risk factors for Torsade de Pointes (e.g. uncompensated heart failure, abnormal
- •potassium or magnesium levels that cannot be corrected, any unstable cardiac condition
- •during the last 30 days, or a family history of long QT syndrome);
- •- The use of concomitant medications that prolong the QT/QTc interval (See Table 5 for
- •4. Patients with evidence of hepatic dysfunction with any of the following abnormalities at the
- •time of enrollment (may be re-checked using local laboratory):
- •Total bilirubin 3 x upper limit of normal (ULN) OR
- •Alanine transaminase or aspartate transaminase 5 x ULN OR
- •Patients with known cirrhosis or chronic hepatic failure
- •5. Concomitant use of sirolimus, astemizole, cisapride, rifampin/rifampicin, rifabutin, ergot
- •alkaloids, long acting barbiturates, ritonavir, efavirenz, carbamazepine, pimozide, quinidine,
- •neostigmine, terfenadine, ketoconazole, valproic acid or St. Johnâ??s Wort in the 5 days prior to
- •first administration of study medication.
- •6. Patients with either chronic aspergillosis, aspergilloma or allergic bronchopulmonary
- •aspergillosis (ABPA).
- •7. Microbiological findings (e.g. virological) or other potential conditions that are temporally
- •related and suggest a different etiology for the clinical features in the absence of evidence of
- •systemic fungal infection.
- •8. Advanced human immunodeficiency virus (HIV) infection with CD4 count 75 or
- •uncontrolled acquired immunodeficiency syndrome-defining condition.
- •9. Any known or suspected condition of the patient that may jeopardize adherence to the
- •protocol requirements or impede the accurate measurement of efficacy (e.g. neutropenia not
- •expected to resolve or patients with fungal endocarditis).
- •10. Patients with a concomitant medical condition that, in the opinion of the investigator, may be
- •an unacceptable additional risk to the patient should he/she participate in the study.
- •11. Patients previously enrolled in a phase III study with ISA (NB patients may be transferred
- •from study WSA-CS-004 if mycology identifies zygomycetes which is not expected to be
- •susceptible to voriconazole).
- •12. Treatment with any investigational drug in any clinical trial 30 days prior to the first
- •administration of study medication except open label protocols.
- •13. Patients who are unlikely to survive 30 days.
- •14. Patients with a body weight 40 kg.
- •15. Patients who need primary therapy for invasive aspergillosis who have been administered
- •more than 4 cumulative days of itraconazole, voriconazole, or posaconazole, for any reason,
- •within the 7 days prior to the first administration of study medication.
- •Patients with applicable host factors who develop new evidence of IFD while on
- •prophylactic therapy, for at least 14 days, with either an amphotericin B product or an
- •echinocandin, will be eligible for enrollment.
- •Prior use of fluconazole of any duration and any reason will
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