Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02652429
• Other study ID #: PULSE-PAH-006
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Bellerophon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Inhaled Nitric Oxide

Locations

Country	Name	City	State
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	University of Alberta Hospitals - MAHI	Edmonton	Alberta
Canada	Lawson Clinical Research Services	London	Ontario
Canada	University Health Network	Toronto	Ontario
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	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	Fernando Torres, MD	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	West Los Angeles VA Healthcare Center	Los Angeles	California
United States	Intermountain Medical Center	Murray	Utah
United States	Mount Sinai Beth Israel	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bellerophon Pulse Technologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Serious Adverse Events	Incidence of Serious Adverse Events from baseline to end of study	Through Study Completion, anticipated 3 years
Primary	Incidence of INOpulse device malfunction and/or device failure leading to an AE	Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study	Through Study Completion, anticipated 3 years