CLINICAL TRIAL

Treprostinil Palmitil for Pulmonary Arterial Hypertension

Recruiting · 18+ · All Sexes · Torrance, CA

This study is evaluating whether treprostinil palmitil inhalation powder is safe and well tolerated in participants with pulmonary arterial hypertension.

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About the trial for Pulmonary Arterial Hypertension

Eligible Conditions
Hypertension · Familial Primary Pulmonary Hypertension · Pulmonary Arterial Hypertension · Respiratory Aspiration

Treatment Groups

This trial involves 2 different treatments. Treprostinil Palmitil is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Treprostinil Palmitil
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participant must be ≥ 18 years of age at the time of signing the informed consent
You have a diagnosis of PH with the following characteristics. show original
Etiology of idiopathic, heritable, drug/toxin-induced or connective tissue disease (CTD)-related PAH
Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest
Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg,
Pulmonary vascular resistance (PVR) of ≥ 3 Wood Units (WU)
No change in pulmonary hypertension medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 90 days prior to Screening
No change in diuretic use or dosage for at least 30 days prior to Screening
You have a body mass index (BMI) within the range 18.0 - 32. show original
You are male and you and your female partner of childbearing potential must agree to use highly effective contraception from Study Day 1 to at least 90 days after dosing. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 1: Pre-treatment (baseline) to 8 and 24 hours post-treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1: Pre-treatment (baseline) to 8 and 24 hours post-treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treprostinil Palmitil will improve 1 primary outcome and 7 secondary outcomes in patients with Pulmonary Arterial Hypertension. Measurement will happen over the course of Day 1 to Day 2.

Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCt1-t2) of Treprostinil Palmitil in the Plasma
DAY 1 TO DAY 2
Maximum Concentration (Cmax) of Treprostinil Palmitil in the Plasma
DAY 1 TO DAY 2
Time to Maximum Concentration (Tmax) of Treprostinil Palmitil in the Plasma
DAY 1 TO DAY 2
Elimination Half-life (t1/2) of Treprostinil Palmitil in the Plasma
DAY 1 TO DAY 2
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Treprostinil Palmitil in the Plasma
DAY 1 TO DAY 2
Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)
DAY 1 UP TO DAY 30
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is pulmonary arterial hypertension?

PAH is a life-threatening disease that progresses rapidly. Symptoms and signs are consistent with that of COPD or CHF. PAH is believed to be the result of an underlying medical disorder. When PAH is diagnosed, its underlying cause needs to be identified as either pulmonary venoocclusive disease or left ventricular outflow tract obstruction and to rule out pulmonary venoocclusive disease. Initial diagnostic evaluation should include high-resolution computed tomography (HRCT), echocardiography, echocardiography with doppler echocardiograph, ventilation/perfusion scanning, exercise stress echocardiography, or magnetic resonance imaging (MRI). Treatment is geared towards controlling symptoms or preventing death.

Anonymous Patient Answer

What are the signs of pulmonary arterial hypertension?

Only a few signs in infancy can lead to the diagnosis of PAH. Only at this time are symptoms of a worsening NYHA stage, or abnormal growth of the heart (cyanosis and enlargement of the upper chest with increased jugular venous pressure).

Anonymous Patient Answer

What are common treatments for pulmonary arterial hypertension?

The treatment in PAH includes vasodilators. This review also outlines the use of non-specific PAH-directed therapy, including in the initial treatment in case of more conservative indications.

Anonymous Patient Answer

How many people get pulmonary arterial hypertension a year in the United States?

Approximately 1 in 5 men (19.6%) had PAH at autopsy. PAH at autopsy was associated with an increased risk of all-cause death and with greater degree of chronic obstructive pulmonary disease.

Anonymous Patient Answer

Can pulmonary arterial hypertension be cured?

Patients with PPH have a variable clinical course. In spite of current medical treatment, many patients experience clinical decompensation, and a high mortality rate. Early identification of this disease may allow clinicians to initiate a multidisciplinary treatment regimen to prevent and/or delay clinical decompensation and improve outcome. In addition, ongoing trials with new modalities of treatment such as pharmacologic preconditioning and stem cell therapies should become increasingly important in reducing long-term mortality.

Anonymous Patient Answer

What causes pulmonary arterial hypertension?

Idiopathic pulmonary arterial hypertension answer: These patients are usually symptomatic at diagnosis and a small number have an underlying disorder that leads to their pulmonary hypertension. Their diagnosis requires consideration of this underlying disorder and of appropriate specific therapy.

Anonymous Patient Answer

How serious can pulmonary arterial hypertension be?

Pulmonary arterial hypertension is a rare and potentially life-threatening condition. Treatment is tailored on an individual basis. Patients in the PTP-6 group and those who have a high degree of disease (PAWP greater than or equal to 75 m/s) (i.e. those at the highest risk of death) have been shown to have a survival advantage. Pulmonary arterial hypertension clinics require [Power (http://www.withpower.com/pulmonary-arterial-hyper-dys-patients/clinical-trials)] to find clinical trials near you. There is an active clinical trial for PAP in patients, and a clinical trial for TAP in the latest updates from the NHS.

Anonymous Patient Answer

Have there been other clinical trials involving treprostinil palmitil?

It is difficult to identify previous studies on treprostinil palmitil. Two studies, published in the year 2000, were excluded by this reviewer because neither report provided sufficient evidence for the trial design or reported adequate patient inclusion to substantiate the results reported. One trial, an open label, was stopped early without reporting enrollment. An open label trial comparing vasopressin to treprostinil for treatment of hyponatremia in ICU trauma patients was also excluded by this reviewer.

Anonymous Patient Answer

What is the primary cause of pulmonary arterial hypertension?

In conclusion, PPH is not typically a cause of pulmonary arterial hypertension in the United States. However, 8-10% of patients with PPH that require transplantation have PPH as a cause of pulmonary arterial hypertension (PAH).

Anonymous Patient Answer

Who should consider clinical trials for pulmonary arterial hypertension?

Many potential patients of PAH are willing to participate in clinical trials, but a limited number is eligible for inclusion in clinical trials because of age or medical comorbidities. On the other hand, very few patients with PAH are eligible for inclusion in clinical trials because their diseases are already treated. Patient age and comorbidities need to be considered before clinical trials are conducted for a particular patient. Furthermore, patients who are unlikely to enroll in clinical trials because their disease is already treated should be offered treatments that are proven to be effective and safe.

Anonymous Patient Answer

Has treprostinil palmitil proven to be more effective than a placebo?

Treprostinil (brand name Remodulin) has been shown to provide a statistically significant improvement in 6-minute walking distance, New York Heart Association (NYHA) class II functional class, and tricuspid regurgitation to be more effective than a placebo.

Anonymous Patient Answer

What are the common side effects of treprostinil palmitil?

Most common side effects of Treprostinil treatment include fatigue, headache, chest pain, nausea, dizziness and cough. The most common adverse events were cough, nausea, fatigue, and headache. Most adverse events were mild or moderate. Treprostinil is well tolerated in patients from all races with moderate to severe pulmonary arterial hypertension.\n

Anonymous Patient Answer
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