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-FUL)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 186
- 试验地点
- 72
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events
研究概览
简要总结
IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
排除标准
- •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.
研究组 & 干预措施
Placebo Crossover AV-101 10 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.
干预措施: AV-101 (Drug)
Placebo Crossover AV-101 35 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
干预措施: AV-101 (Drug)
Placebo Crossover AV-101 70 mg
Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
干预措施: AV-101 (Drug)
Continuing AV-101 10 mg
Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.
干预措施: AV-101 (Drug)
Continuing AV-101 70 mg
Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
干预措施: AV-101 (Drug)
Continuing AV-101 35 mg
Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.
干预措施: AV-101 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events
时间窗: From date of first dose to 30 days after date of last dose (up to approximately 21 months)
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
次要结局
未报告次要终点