Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT05356052
• Other study ID #: PULSE-EAP-002
• Status: Available

Study information

• Verified date: April 2022
• Source: Bellerophon
• Contact: Bobae Kim
• Phone: 917-675-2254
• Email: bobae.kim[@]bellerophon.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Fibrosis
• Pulmonary Hypertension

Intervention

Combination Product:
• INOpulse
Patients will be treated by means of an INOpulse device using an INOpulse nasal cannula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bellerophon