NCT00391443已完成3 期
Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.
Actelion0 个研究点目标入组 616 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 616
- 主要终点
- Time to Occurrence of Disease Worsening or Death up to End of Study.
研究概览
简要总结
BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male or female aged 18 years or older (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception.)
- •Proven diagnosis of IPF according to American Thoracic Society / European Respiratory Society (ATS-ERS) statement, of <3 years, with surgical lung biopsy (SLB)
排除标准
- •Interstitial lung disease due to conditions other than IPF.
- •Presence of extensive honeycombing (HC) on baseline high-resolution computed tomography (HRCT) scan.
- •Severe concomitant illness limiting life expectancy (<1 year).
- •Severe restrictive lung disease.
- •Obstructive lung disease.
- •Diffusing capacity of the lung for carbon monoxide <30% predicted.
- •Residual volume > or = 120% predicted.
- •Documented sustained improvement of patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
- •Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
- •Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements.
- •Chronic heart failure with New York Heart Association (NYHA) class III/IV or known left ventricular ejection fraction <25%.
- •Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) > 1.5 times the upper limit of the normal ranges.
- •Moderate to severe hepatic impairment.
- •Serum creatinine > or = 2.5 mg/dl or chronic dialysis.
- •Hemoglobin concentration <75% the lower limit of the normal ranges.
- •Systolic blood pressure <85 mmHg.
- •Pregnancy or breast-feeding.
- •Current drug or alcohol dependence.
- •Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of randomization):oral corticosteroids (>20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of N-acetylcysteine (prescribed for IPF).
- •Oral anticoagulants other than those indicated for a venous or arterial thrombotic disease.
- •Treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine A, tacrolimus) up to 1 week prior to randomization.
- •Treatment with an endothelin receptor antagonist up to 3 months prior to randomization.
- •Participation in the BUILD 1 trial.
- •Treatment with another investigational drug up to 3 months prior to randomization or planned treatment.
- •Known hypersensitivity to bosentan or any of the excipients.
研究组 & 干预措施
Bosentan
Experimental
Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight > 40 kg) or bosentan 62.5 mg b.i.d. (if body weight < 40 kg)
干预措施: Bosentan (Drug)
Placebo
Placebo Comparator
Subjects receive placebo matching the bosentan treatment regimen
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Occurrence of Disease Worsening or Death up to End of Study.
时间窗: 36 months
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
次要结局
- Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.(12 months)
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