Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis

NCT05356052 | Unknown

• 1 other identifier: PULSE-EAP-002
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Interventions

INOpulse COMBINATION_PRODUCT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
• Subjects greater than 18 years of age at the time of consent to study participation.
• Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials.
• 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.
• 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.
• Subjects, in the opinion of the Investigator that would benefit from iNO treatment.

You may not qualify if:

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

Sponsors & Collaborators

• Bellerophon: lead

MeSH Terms

Conditions

Pulmonary Fibrosis; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ashika Ahmed, MD

  Bellerophon Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Bobae Kim

CONTACT

917-675-2254; bobae.kim@bellerophon.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Last Updated: February 21, 2023

Record last verified: 2022-04