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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bellerophon Pulse Technologies
• Treatments: Nitric Oxide

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