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Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05356052
Enrollment
Unknown
Registered
2022-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis, Pulmonary Hypertension

Keywords

PF, Pulmonary Fibrosis, Pulmonary Hypertension, PH, Inhaled Nitric Oxide, iNO, Long Term Oxygen Therapy, LTOT, Oxygen, INOpulse, pulsed inhaled nitric oxide, fILD, fibrotic interstitial lung disease, portable pulsed inhaled nitric oxide

Brief summary

An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.

Interventions

COMBINATION_PRODUCTINOpulse

Patients will be treated by means of an INOpulse device using an INOpulse nasal cannula

Sponsors

Bellerophon
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments. 2. Subjects greater than 18 years of age at the time of consent to study participation. 3. Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials. 4. 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. 5. Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy. 6. Subjects, in the opinion of the Investigator that would benefit from iNO treatment.

Exclusion criteria

1. Subjects who require treatment with riociguat. 2. Clinical contraindication to inhaled nitric oxide, as deemed by the Investigator. 3. Subjects who require concurrent Positive Airway Pressure (PAP) or Positive End Expiratory Pressure (PEEP). 4. Concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.

Contacts

Primary ContactBobae Kim
bobae.kim@bellerophon.com917-675-2254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026