Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis
NCT ID: NCT05356052
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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INOpulse
Patients will be treated by means of an INOpulse device using an INOpulse nasal cannula
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Bellerophon
INDUSTRY
Responsible Party
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Principal Investigators
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Ashika Ahmed, MD
Role: STUDY_DIRECTOR
Bellerophon Therapeutics
Central Contacts
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Other Identifiers
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PULSE-EAP-002
Identifier Type: -
Identifier Source: org_study_id
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