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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.
Must not have
Evidence of thromboembolic disease, active liver disease, HIV infection, hepatitis B or C viral infections, or symptomatic COVID-19.
History of PH other than specified subtypes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing an inhalable medicine called TPIP to see if it can help people with high blood pressure in their lungs by making it easier for blood to flow through their lung arteries.
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.
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.
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.
Select...
I have been diagnosed with a specific type of high blood pressure in the lungs.
Select...
I am between 18 and 75 years old.
Select...
I am a man and will use birth control if my partner can have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of blood clots, liver disease, HIV, hepatitis B or C, or symptomatic COVID-19.
Select...
I have a history of pulmonary hypertension, but not the specified types.
Select...
I have specific heart conditions or recently joined a heart-lung rehab program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2014 Phase 4 trial • 20 Patients • NCT0305522131%
Pyrexia
25%
Catheter site infection
19%
Nausea
19%
Device-related infection
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%
Sepsis
6%
Pyogenic granuloma
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pulmonary Arterial Hypertension (PAH) include prostacyclin analogs, phosphodiesterase-5 inhibitors (PDE5Is), and endothelin receptor antagonists (ERAs). Prostacyclin analogs, such as treprostinil, dilate blood vessels and inhibit platelet aggregation, reducing pulmonary vascular resistance and improving blood flow.
PDE5Is, like sildenafil, enhance nitric oxide effects, leading to vasodilation and better hemodynamics. ERAs, such as bosentan, block endothelin-1, a vasoconstrictor, reducing vascular resistance.
These mechanisms are vital for PAH patients as they alleviate symptoms, improve exercise capacity, and potentially enhance survival.
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.
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