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Prostacyclin Analogue
Treprostinil Palmitil for PAH
Phase 2 & 3
Recruiting
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-ole baseline (baseline of the lead-in tpip study), months 6, 12, 18, and 24
Awards & highlights
Study Summary
This trial tests if a drug is safe and tolerable for long-term use to treat Pulmonary Arterial Hypertension.
Who is the study for?
This trial is for men and women who have completed previous TPIP studies for PAH within the last year. They must not have started parenteral prostacyclin analogues since their last study but can join if they've stopped certain inhaled or oral treatments at least a day before starting this trial.Check my eligibility
What is being tested?
The study tests the long-term safety of Treprostinil Palmitil Inhalation Powder (TPIP) in people with Pulmonary Arterial Hypertension. Participants from earlier TPIP trials will either continue with TPIP or receive a placebo to compare effects over time.See study design
What are the potential side effects?
While specific side effects are not listed, participants will be monitored for any adverse reactions due to long-term use of TPIP, which could include issues related to lung function, blood pressure changes, or other drug-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I completed a previous PAH study with INS1009.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-ole baseline (baseline of the lead-in tpip study), months 6, 12, 18, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-ole baseline (baseline of the lead-in tpip study), months 6, 12, 18, and 24
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 at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity
Secondary outcome measures
Absolute Change From Pre-Open Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Annualized Clinical Worsening Event Rate
Change From Pre-OLE Baseline in New York Heart Association/ World Health Organization (NYHA/WHO) Functional Capacity Class
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treprostinil Palmitil Inhalation Powder (TPIP)Experimental Treatment2 Interventions
Participants who are not transitioning immediately from other TPIP studies:INS1009-201(NCT04791514), INS1009-202(NCT05147805) and other lead-in studies, will be given TPIP, once daily (QD), starting with 80 micrograms (μg), up-titrated to highest tolerated dose between 80 μg and 640 μg during 3-week titration period that maybe increased upto maximum dose of 1280 μg QD post initial titration, per investigator's assessment. Overall treatment period=24 months.
Participants transitioning immediately from randomized blinded lead-in TPIP study and who previously received:
TPIP- will be given placebo QD(80 μg upto achieved TPIP dose from previous study)along with achieved TPIP dose from previous study in blinded manner during 3-week titration period.
Placebo- will be given TPIP QD (80 μg up to achieved placebo dose from previous study)along with achieved placebo dose from previous study in blinded manner during 3-week titration period.Overall treatment period=24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil Palmitil
2022
Completed Phase 2
~40
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,102 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
100 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stopped my inhaled or oral prostacyclin treatments 24 hours before starting the study drug.I completed a lead-in study less than a year ago and couldn't join the follow-up study then.I started using injectable prostacyclin analogues after participating in specific clinical studies.I completed a previous PAH study with INS1009.
Research Study Groups:
This trial has the following groups:- Group 1: Treprostinil Palmitil Inhalation Powder (TPIP)
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.
Are there numerous sites managing this study?
"Currently, 8 research centres are actively recruiting participants for this study. These sites span Chicago, Dallas and Makati City as well as other cities; it is advised to choose the closest site in order to reduce travelling demands if one decides to take part."
Answered by AI
Is this investigation currently onboarding participants?
"Affirmative. As documented on clinicaltrials.gov, this medical trial is actively looking for volunteers to enrol; it was first posted on March 7th 2023 and last updated on May 16th 2023. In total, 100 participants need to be recruited from 8 different locations across the country."
Answered by AI
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