EUCTR2022-002007-38-NL进行中（未招募）1 期
An open-label extension study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Written informed consent must be obtained before any assessment is performed.
- •Participant is currently completing the Novartis-sponsored study
- •CLTP001A12201 in PAH and completed key efficacy and safety
- •procedures up to the end of treatment of the parent study, without
- •meeting discontinuation criteria in the parent study.
- •Willingness and ability to comply with scheduled visits, treatment
- •plans and any other study procedures.
- •In the opinion of the Investigator the participant would benefit from
- •LTP001 treatment.
- •Additional protocol-defined criteria may apply.
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •History of hypersensitivity to the study treatment.
- •Required or planned transplant or heart/lung surgery.
- •Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity or execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, need for walking aids).
- •Permanent discontinuation of Novartis drug in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason.
- •Additional protocol-defined criteria may apply.
研究者
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