Early Feasibility Study Evaluating the 3P-100 Device in Subjects With PH-ILD

Running, not enrolling · Not applicable

Conditions studied: Hypertension, Pulmonary, Lung Diseases, Interstitial

In brief

A trial to evaluate the safety, tolerability, and functionality of 3P-100, in subjects with Pulmonary Hypertension (PH) accompanying Interstitial Lung Disease (ILD), PH-ILD

Key facts

Study ID

NCT05867914

Run by

Third Pole Therapeutics, Inc.

People needed

5

Starts

2023-12-04

Expected to finish

2024-03-29

Last updated by the study team

2024-02-14

Who can join

Age: 22 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age 22 to < 85 years old
• Provides signed informed consent for study participation
• Diagnosis of any form of advanced Interstitial Lung Disease or Combined Pulmonary Fibrosis and Emphysema (CPFE) at any time, based on clinical, pulmonary function, serological, and Computed Tomography (CT) radiologic evidence (which demonstrates evidence of moderate to severe diffuse parenchymal lung disease)
• A prior Right Heart Catheterization (RHC) at any time before SV that demonstrates PH with a Pulmonary Vascular Resistance (PVR) >2.0 Wood Units (WU), a mean Pulmonary Arterial Pressure (mPAP) > 20 mmHg, and a Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg. A PCWP >15 mmHg is not exclusionary if a left ventricular end diastolic pressure (LVEDP) is available and is ≤ 15 mmHg by left heart catheterization AND/OR Previous Echocardiography with an intermediate/high probability of PH (European Society of Cardiology definition)
• New York Heart Association (NYHA) functional class II-IV
• Self-reported use of long-term O2 therapy (LTOT) less than or equal to 10 L/minute at rest and while exercising, defined as use for at least 12 hours per day for at least 30 days prior to SV
• Is willing to comply with treatment with iNO and procedures including using the 3P-100 device and wearing a nasal cannula for at least 4 hours at V1
• Is able to wear a 3P-100 device while sitting and ambulating intermittently in the clinic area for at least 30 minutes during SV
• Women of child-bearing potential must agree to use the methods of birth control indicated in Appendix 1 from consent through the Telephone Call at V1 +1 Day

You may not qualify if…

• History or diagnosis by Investigator evaluation during SV of World Health Organization (WHO) Group I, II, IV, or V PH
• NYHA class IV patients who are medically unfit to participate i.e., are constantly breathless at rest or have frequent symptoms of chest pain or syncope at rest or with activity
• History or diagnosis of acute or chronic left heart failure at any time as evidenced by one or more of the following:
• PCWP > 15 mmHg on a previous RHC (unless LVEDP is ≤15 mmHg) AND/OR LVEDP >15 mmHg by left heart catheterization
• Previous echocardiographic findings of left ventricular systolic dysfunction with ejection fraction < 40%
• Cardiogenic pulmonary edema
• History of left heart failure (Prior or current use of medications given solely for the treatment of systemic hypertension are allowed)
• History of hereditary methemoglobinemia
• History of the following cardiovascular conditions:
• Stenting or Coronary Artery Bypass Graft (CABG) within 60 days prior to SV
• Myocardial infarction within the 60 days prior to SV
• Unstable angina pectoris in the 60 days prior to SV
• Intermittent atrial fibrillation, supraventricular tachycardia, and serious ventricular arrhythmias (e.g., ventricular tachycardia) within 60 days prior to SV. Ablated atrial flutter or Wolf-Parkinson-White (WPW) bypass tract conduction are not exclusionary
• Cerebrovascular accident within the 60 days prior to SV
• Has within 30 days prior to SV or during the Screening period
• Participated in any clinical study involving an investigational drug, investigational biologic, or investigational device
• Required unplanned hospitalization for any reason
• Had an exacerbation of ILD requiring administration of oral or parenteral antibiotic
• Has within the 30 days prior to SV or during the Screening period required initiation or changes in the regimen (including agents, dose, and frequency) of medications prescribed for the treatment of ILD, including but not limited to immunosuppressive / immunomodulatory medications, systemic oral or parenteral corticosteroids, and monoclonal antibodies
• Has within 30 days prior to SV, or any time during Screening period taken one or more of the following medications or supplements chronically:
• Oral, inhaled, or parenteral medications for the treatment of Pulmonary Arterial Hypertension (PAH) irrespective of the route of administration including, but not limited to,
• high dose calcium channel blockers
• riociguat
• prostacyclins
• prostacyclin analogues

Where it is running

• TGH/USF Center for Advanced Lung Disease and Lung Transplant — Tampa, Florida, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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