EUCTR2006-000374-75-GB进行中（未招募）1 期
ong-term, open-label, multicenter extension study of bosentan in patients with pulmonary hypertension associated with sickle cell disease completing a double-blind ASSET study (AC-052-368 or AC-052-369) - ASSET-3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 316
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
- •1.Completion of the 16-week treatment period in the double-blind ASSET study
- •2.Women of childbearing potential must have a negative result on their serum pregnancy test and use reliable methods of contraception during study treatment and for 3 months after study treatment termination.
- •3.Signed written informed consent is obtained from the patient or patient’s parent/ legal representative prior to initiation of any study-related procedure.
- •Are the trial subjects under 18? yes
- •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
- •All patients (Groups A and B):
- •1.Any major protocol violation in the preceding double-blind ASSET study
- •2.Hemoglobin concentration < 6.0 g/dL
- •3.Pregnancy or breast-feeding
- •Group B only:
- •4.Acute liver disease
- •5.Newly diagnosed cirrhosis or portal hypertension
- •6.ALT = 3 times the upper limit of normal (ULN) and/or albumin > 20% below the lower limit of normal (LLN)
- •7.Newly diagnosed psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
研究者
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