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Prostacyclin Analogue

Treprostinil Palmitil for Pulmonary Arterial Hypertension

Phase 2
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: pre-treatment (baseline), 8 and 24 hours post-treatment
Awards & highlights

Study Summary

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

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-treatment (baseline), 8 and 24 hours post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: pre-treatment (baseline), 8 and 24 hours post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)
Secondary outcome measures
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Treprostinil (TRE) in Pasma
Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of Treprostinil (TRE) in Plasma
Change From Baseline in Pulmonary Vascular Resistance (PVR) After TPIP Administration
+3 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT03055221
31%
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

1Treatment groups
Experimental Treatment
Group I: Treprostinil Palmitil Inhalation PowderExperimental Treatment1 Intervention
Participant received a single dose of TPIP 112.5 micrograms (μg) via oral inhalation on Day 1. The participant then entered into a 16-week Extended Use Treatment (EUT) Period during which TPIP, administered via oral inhalation, was titrated up to a mean daily dose of 320 μg.
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
7,201 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
199 Patients Enrolled for Pulmonary Arterial Hypertension

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)
2022. "A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04791514.
~0 spots leftby Apr 2025
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