NL-OMON53603尚未招募3 期
IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 - IMPAHCT-F
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects who have consented to participate.
- •2. Subjects who have successfully completed the placebo-controlled 24-week
- •study AV-101-002 without a treatment-limiting toxicity resulting in
- •discontinuation of study drug.
- •3. Female subjects of childbearing potential who have agreed to continue to use
- •a highly effective form of contraception during the LTE and for at least 30
- •days after completing or discontinuing study treatment.
排除标准
- •1. Subjects for whom the investigator believes that it would not be in the best
- •interest of the subject to be included in the LTE e.g., for clinical or social
- •2. Subjects who were not compliant with study medication in AV-101-002 as
- •assessed by the Investigator.
- •3. Clinically relevant history or current psychological abnormality (including
- •alcohol abuse), psychiatric or neurological illness or autonomic neuropathy,
- •which in the opinion of the Investigator could jeopardize or would compromise
- •the subject*s ability to participate in the trial.
- •4. Recent major surgical intervention which in the opinion of the Investigator
- •would compromise the subject*s ability to participate in the trial.
- •5. Pregnant or breast-feeding females
研究者
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