An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 22
- 试验地点
- 17
- 主要终点
- Incidence of Serious Adverse Events
研究概览
简要总结
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
详细描述
An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
- •PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
- •Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
- •All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
- •Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.
排除标准
- •Subjects who require treatment with riociguat
- •Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201
研究组 & 干预措施
Inhaled Nitric Oxide (iNO)
Pulsed iNO 75 mcg/kg IBW/hour
干预措施: Inhaled Nitric Oxide (Drug)
结局指标
主要结局
Incidence of Serious Adverse Events
时间窗: Through Study Completion, anticipated 3 years
Incidence of Serious Adverse Events from baseline to end of study
Incidence of INOpulse device malfunction and/or device failure leading to an AE
时间窗: Through Study Completion, anticipated 3 years
Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study
次要结局
未报告次要终点