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

Bellerophon Therapeutics

Status and phase

Unknown

Phase 3

Conditions

Pulmonary Arterial Hypertension

Treatments

Drug: Inhaled Nitric Oxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02652429

PULSE-PAH-006

Details and patient eligibility

About

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

Full 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.

Enrollment

22 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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