EUCTR2021-006864-25-NL进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 462
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
- 性别
- All
入选标准
- •Key Inclusion Criteria: (Additional criteria, may apply, per the protocol)
- •To be eligible, a participant is required to be or have:
- •Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.
- •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 (highly effective forms of contraception).
- •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 323
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 139
排除标准
- •Key Exclusion Criteria:
- •Subjects meeting any of the following criteria:
- •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 reasons.
- •Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator
研究者
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3 期
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