Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Sponsor
Bellerophon (Industry)
Overall Status
Available
CT.gov ID
NCT05356052
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: INOpulse

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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 and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bellerophon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bellerophon
    ClinicalTrials.gov Identifier:
    NCT05356052
    Other Study ID Numbers:
    • PULSE-EAP-002
    First Posted:
    May 2, 2022
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022

    Study Results

    No Results Posted as of May 2, 2022