Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension

Bellerophon0 个研究点开始时间: 2022年5月2日最近更新: 2023年2月21日

适应症

试验速览

阶段: 不适用
状态: Available
发起方: Bellerophon

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
•Subjects greater than 18 years of age at the time of consent to study participation.
•Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials.
•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.
•Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
•Subjects, in the opinion of the Investigator that would benefit from iNO treatment.

排除标准

•Subjects who require treatment with riociguat.
•Clinical contraindication to inhaled nitric oxide, as deemed by the Investigator.
•Subjects who require concurrent Positive Airway Pressure (PAP) or Positive End Expiratory Pressure (PEEP).
•Concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.

研究者

发起方

Bellerophon

申办方类型

Industry

责任方

Sponsor

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