Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: Inhaled Nitric Oxide
- Registration Number
- NCT02652429
- Lead Sponsor
- Bellerophon Pulse Technologies
- Brief Summary
An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inhaled Nitric Oxide (iNO) Inhaled Nitric Oxide Pulsed iNO 75 mcg/kg IBW/hour
- Primary Outcome Measures
Name Time Method Incidence of Serious Adverse Events 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
Lawson Clinical Research Services
🇨🇦London, Ontario, Canada
UC Health University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University, Wexner Medical Center
🇺🇸Columbus, Ohio, United States
West Los Angeles VA Healthcare Center
🇺🇸Los Angeles, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Fernando Torres, MD
🇺🇸Dallas, Texas, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
University of Alberta Hospitals - MAHI
🇨🇦Edmonton, Alberta, Canada