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Prostacyclin Analogue
Treprostinil Palmitil for Pulmonary Arterial Hypertension
Phase 2
Recruiting
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be on stable PH therapy with specific medications and no changes in medication or dosage for at least 30 days prior to Screening.
Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) [pulmonary arterial hypertension (PAH)] in specific subtypes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, weeks 2, 3, 5, 10, and 16: predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Awards & highlights
Study Summary
This trial will compare the effects of treprostinil palmitil inhalation powder to a placebo on pulmonary vascular resistance in people with Pulmonary Arterial Hypertension.
Who is the study for?
Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who are on stable PH therapy can join this trial. They must not smoke, have a history of certain heart diseases or infections, and women should use effective contraception. Participants need to be able to perform physical tests like walking.Check my eligibility
What is being tested?
The study is testing Treprostinil Palmitil inhalation powder against a placebo to see if it improves blood flow resistance in the lungs for PAH patients. The participants will either receive the actual drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for inhaled PAH treatments include coughing, headaches, nausea, dizziness, and potential risks associated with inhaling medication directly into the lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been on the same pulmonary hypertension medication for at least 30 days.
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I have been diagnosed with a specific type of high blood pressure in the lungs.
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I am between 18 and 75 years old.
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I am a man and will use birth control if my partner can have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, weeks 2, 3, 5, 10, and 16: predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, weeks 2, 3, 5, 10, and 16: predose and 0.5, 1, 2 ,4 and 6 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Pulmonary Vascular Resistance at Week 16
Secondary outcome measures
Apparent Total Clearance (CL/F) of Treprostinil
Apparent Total Clearance (CL/F) of Treprostinil Palmitil
Apparent Volume of Distribution After Non-Intravenous Administration (Vd/F) of Treprostinil
+21 moreSide effects data
From 2014 Phase 4 trial • 20 Patients • NCT0305522131%
Pyrexia
25%
Catheter site infection
19%
Device-related infection
19%
Nausea
19%
Abdominal discomfort
19%
Catheter site pain
19%
Device dislocation
19%
Cough
13%
Device-related sepsis
13%
Diarrhoea
13%
Vomiting
13%
Pain in extremity
13%
Pain in jaw
13%
Dyspnea
13%
Oropharyngeal pain
13%
Bacteraemia
13%
Headache
6%
Pyogenic granuloma
6%
Sepsis
6%
Endocarditis
6%
Localized infection
6%
Lower respiratory tract infection
6%
Nasopharyngitis
6%
Pleural effusion
6%
Pleurisy
6%
Pulmonary arterial hypertension
6%
Abortion induced
6%
Thrombophlebitis
6%
Venous thrombosis
6%
Cyanosis
6%
Lacrimation increased
6%
Local swelling
6%
Wound infection
6%
Wound haemorrhage
6%
Weight decreased
6%
Muscle spasms
6%
Decreased appetite
6%
Coagulopathy
6%
Pulmonary hypertension
6%
Cardiac failure acute
6%
Cardiac failure congestive
6%
Right ventricular failure
6%
Vertigo
6%
Catheter site swelling
6%
Chills
6%
Disease progression
6%
Infusion site pain
6%
Hepatomegaly
6%
Atypical pneumonia
6%
Pneumonia
6%
Septic shock
6%
Polymenorrhea
6%
Interstitial lung disease
6%
Lung consolidation
6%
Musculoskeletal chest pain
6%
Epistaxis
6%
Productive cough
6%
Rhinorrhoea
6%
Chest pain
6%
Haematuria
6%
Pain
6%
Oedema
6%
Insomnia
6%
Gynacomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Treprostinil
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treprostinil Palmitil Inhalation PowderExperimental Treatment1 Intervention
Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be up-titrated to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered a placebo matching TPIP once per day for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil Palmitil
2022
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,103 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
101 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clots, liver disease, HIV, hepatitis B or C, or symptomatic COVID-19.I am allergic or sensitive to certain medications.I have a history of pulmonary hypertension, but not the specified types.I have been diagnosed with pulmonary arterial hypertension for over 3 months.I've been on the same pulmonary hypertension medication for at least 30 days.I am following the required guidelines for contraception, sterilization, or am post-menopausal.I have specific heart conditions or recently joined a heart-lung rehab program.I have been diagnosed with a specific type of high blood pressure in the lungs.I do not have Down's Syndrome, abnormal bleeding, organ transplants, immune disorders, or recent substance abuse.I have not received any live vaccines in the last 30 days.I am between 18 and 75 years old.I am a man and will use birth control if my partner can have children.
Research Study Groups:
This trial has the following groups:- Group 1: Treprostinil Palmitil Inhalation Powder
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you tell me if individuals above the age of 50 are eligible for this program?
"As this trial's eligibility criteria state, individuals must be between 18-75 years old to participate."
Answered by AI
Are there any medical prerequisites to joining this research project?
"The eligibility requirements for this study are that potential participants must have a diagnosis of pulmonary arterial hypertension and be between 18-75 years old. They are looking to recruit approximately 99 patients in total."
Answered by AI
Has the FDA cleared Treprostinil Palmitil for use?
"While there is some data indicating that Treprostinil Palmitil is safe, there is currently no evidence to support its efficacy. Therefore, it received a score of 2."
Answered by AI
How many study participants are being monitored for this research?
"The trial is actively recruiting patients, as recent as 9/23/2022, according to information found on clinicaltrials.gov. This specific study is looking for 99 individuals total, across 15 different sites."
Answered by AI
Are there a lot of places in Canada where this research is taking place?
"At the moment, this clinical trial is open to patients at USA005 in Jacksonville, Florida, USA017 in New york, New York, and USA016 in Dallas, Texas. Additionally, there are 15 other sites across the nation where patients can participate."
Answered by AI
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