Clinical trial NCT02652429: Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Pulmonary Arterial Hypertension
Inhaled Nitric Oxide
iNO
Lead sponsor: Bellerophon
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Extension
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Serious Adverse Events
timeFrame: Through Study Completion, anticipated 3 years
measure: Incidence of INOpulse device malfunction and/or device failure leading to an AE
timeFrame: Through Study Completion, anticipated 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: West Los Angeles VA Healthcare Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University, Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Fernando Torres, MD
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospitals - MAHI
state: Alberta
city: London
country: Canada
facility: Lawson Clinical Research Services
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Bellerophon Therapeutics
name: Ashika Ahmed, MD
role: STUDY_DIRECTOR
References: