EUCTR2004-000365-35-GB进行中（未招募）1 期
Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell Transplants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
入选标准
- •Male and female patients with previous proven or probable IFI* in the previous six months, who will be receiving allogeneic SCT for acute leukemia or acute transformation of chronic myeloid leukemia.
- •*according to Ascioglu criteria
- •Signed and dated informed consent will be obtained.
- •Females of childbearing potential must have a negative serum B-HCG pregnancy test and be practicing an effective form of contraception.
- •Age >= 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or lactating women, or women of childbearing potential not
- •using an acceptable method of contraception
- •Severe disease other than underlying condition, likely to jeopardize the planned termination of the study (e.g. acute myocardial infarction, unstable angina pectoris, potentially proarryhthmic conditions such as cardiac impairment due to previous cardiotoxic chemotherapy, previous torsade de pointes, prolongation of the QT interval > 450 msec for men or > 470 msec for women)
- •Abnormal baseline findings considered by the investigator to be
- •indicative of conditions that might affect study results (e.g. short bowel
- •Previous history of zygomycosis (eg Mucor, Absidia, Rhizopus)
- •Positive serum galactomannan antigen test (ratio > or = 1.0)
- •Active, symptomatic, uncontrolled IFI (persistence of clinical
- •symptoms related to active fungal disease)
- •Any evidence of active fungal disease as defined by
- •the MSG-EORTC criteria, i.e. persistence of positive microbiological
- •blood cultures or Aspergillus antigenemia, at time of enrollment (Visit 2)
- •Present candiduria
- •Previous failure of voriconazole in the treatment of IFI
- •Concomitant use of voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
- •Known intolerance to azole compounds
- •Concomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole,
- •cisapride, pimozide, quinidine, carbamazepine, rifampicin,
- •phenobarbital, ritonavir or efavirenz which might interfere with the
- •evaluation of study drugs during the study specific systemic diseases
- •Other medical conditions, including HIV-positive serology, that would
- •interfere with the evaluation of the therapeutic response or safety of the
- •Alcohol and/or any other drug abuse
- •Previous participation in this trial
- •Abnormal laboratory test results, defined as impaired hepatic function,
- •as shown by but not limited to transaminases, alkaline phosphatases,
- •or bilirubin > 5 x Upper Limit of Normal [ULN]
- •Impaired renal function, as shown by but not limited to estimated
- •creatinine clearance (Clcr) < 50 mL/minute (as per Cockroft-Gault
- •Any other condition which, in the investigator's judgment, might
- •increase the risk to the subject or decrease the chance of obtaining
- •satisfactory data to achieve the objectives of the study
- •Mental condition rendering the subject unable to understand the nature,
- •scope and possible consequences of the study and/or evidence of an
- •uncooperative attitude
- •Unable and/or unlikely to comprehend and/or follow the protocol
- •Participation in any other studies involving investigational or marketed
- •products, concomitantly or within 30 days prior to entry in the study
- •Anticipated survival less than 72 hours
研究者
相似试验
进行中（未招募）
1 期
Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell TransplantsEUCTR2004-000365-35-ESPfizer S.A75
已完成
Unknown
A study to determine safety and effectiveness of Budesonide-Formoterol given through the Ciphaler device in patients with Asthma.CTRI/2023/06/053727Cipla Ltd200
招募中
4 期
A clinical study to understand the effect of Remdesivir intravenous injection in hospitalized moderate to severe Covid-19 patients.CTRI/2022/03/041252CiplaLtd
已完成
3 期
To determine the safety and efficacy of Etanercept for injection 25 mg in patients with moderate to severe active rheumatoid arthritis.CTRI/2009/091/000399Cipla Ltd R and D Centre LBS Marg Vikhroli W Mumbai100
进行中（未招募）
4 期
An open label, phase IV trial of Glycopyrronium/Formoterol/Budesonide (25mcg/12mcg/400mcg) fixed dose triple combination (FDC) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).CTRI/2021/08/035992Cipla Ltd