EUCTR2007-005117-18-AT进行中（未招募）不适用
Safety and efficacy study of bosentan in progressive pulmonary sarcoidosis - BOPSAC
Medical University of Vienna, Department of Clinical Pharmacology0 个研究点开始时间: 2008年3月4日最近更新:
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
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
- •Signed informed consent prior to any study-mandated procedure.
- •Male and female patients aged > 18 and < 70 yrs.
- •Histologically proven sarcoidosis diagnosed at least one year before screening.
- •Diagnosis of sarcoidosis and with evidence of pulmonary parenchymal disease on chest X-ray or CT (radiological stage II, III) with or without pulmonary hypertension. Subjects with concurrent extrapulmonary sarcoidosis are encouraged to be enrolled.
- •Progressive disease, defined as follows:
- •o Deterioration in the 3-12 month period prior to screening in at least two of the
- •following criteria:
- •- increase in clinical symptoms (cough, shortness of breath, chest pain,
- •fatigue or hemoptysis).
- •- lung function: decrease of 10 % in TLC, FVC or DLCO.
- •- worsening of radiographic opacities.
- •o Have been receiving pre-study treatment with prednisolone (or equivalent
- •dose of corticosteroid) as a single agent (= 10 mg/day) or other
- •immunosuppressants (methotrexate, azathioprine, cyclophosphamide, TNF
- •inhibitors, etc.) within the 3-month period immediately prior to screening.
- •Patients must be on a stable dose of these medicatins for > 4 weeks before
- •starting the study medication.
- •AST and ALT values within three times upper limit of normal.
- •Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
- •Negative pregnancy test in female patients.
- •Adequate contraception in female patients of childbearing age.
- •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
- •Known hypersensitivity to any excipients of the drug formulation or to bosentan.
- •Treatment with another investigational drug within 3 months prior to screening.
- •Pulmonary sarcoidosis
- •o without disease progression as defined above
- •o with radiological stage I
- •o with radiological stage IV (pulmonary fibrosis with evidence of honey-combing,
- •hilar retraction, bullae and cysts)
- •Other cause of pulmonary disease:
- •o Active tuberculosis (or positive Quantiferon test), fungi infection, lymphoma.
- •o Chronic obstructive pulmonary disease, asthma, interstitial lung disease other
- •than sarcoid-related
- •Anamnesis of beryllium or asbestos exposition
- •Previous smoking (> 10 PY), or active smoker
- •Previous administration of bosentan
- •Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- •Positive results from the HIV serology at screening.
- •Malignancy requiring chemotherapy or radiation
- •Uncontrolled other disease like
- •o Chronic heart failure (NYHA III, IV)
- •o Diabetes mellitus (blood glucose 2x per day > 250 mg/dl , HbA1c > 10 %)
- •o Arterial hypertension (SBP > 180 mmHg)
- •Concomitant treatment with cyclosporine A
- •Concomitant treatment with tacrolimus or sirolimus
- •Concomitant treatment with glibenclamid
- •Are pregnant, nursing, or planning pregnancy during the trial or within six month period thereafter
- •Have a known substance dependency (drug or alcohol within 3 years of screening)
- •Presumed non-compliance.
- •Legal incapacity or limited legal capacity at screening.
研究者
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