NCT00631475已完成3 期
Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)
Actelion0 个研究点目标入组 128 人开始时间: 2008年4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
- 128
- 主要终点
- Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
研究概览
简要总结
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients should have completed all the assessments from the BUILD 3 (NCT00391443) end of study (EOS) visit.
- •Signed informed consent prior to initiation of any study-related procedures.
- •Women of childbearing potential must have a negative serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.
排除标准
- •Any major violation of protocol AC-052-321 / BUILD 3 (NCT00391443).
- •Pregnancy or breast-feeding.
- •AST and/or ALT > 3 times the upper limit of the normal range.
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
- •Known hypersensitivity to bosentan or any of the excipients.
研究组 & 干预措施
1
Experimental
For patients who were administered bosentan during BUILD 3 (NCT00391443):
Same dose will continue
For patients who were administered placebo during BUILD 3 (NCT00391443):
Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg
干预措施: Bosentan (Drug)
结局指标
主要结局
Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
时间窗: Start of study to end of study, up to 21 months
Mean extent of exposure to bosentan treatment in months
次要结局
- Number of Patients Exposed to Bosentan Over Time(Start to end of study, up to 21 months)
- Adverse Events (AE) Leading to Discontinuation of Study Drug.(Start to end of study, up to 21 months)
- Treatment-emergent Serious Adverse Events (SAE)(up to 21 months plus 28 days after the end of study drug)
- Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.(up to 21 months, plus 24 hours after the end of study treatment)
研究者
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