Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Primary Purpose
Pulmonary Fibrosis, Pulmonary Hypertension
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
INOpulse
Sponsored by
About this trial
This is an expanded access trial for Pulmonary Fibrosis focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05356052
Brief Title
Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Official Title
Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bellerophon
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Combination Product
Intervention Name(s)
INOpulse
Intervention Description
Patients will be treated by means of an INOpulse device using an INOpulse nasal cannula
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bobae Kim
Phone
917-675-2254
Email
bobae.kim@bellerophon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashika Ahmed, MD
Organizational Affiliation
Bellerophon Therapeutics
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis
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