Treprostinil for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Massachusetts General Hospital, Boston, MAPulmonary Arterial Hypertension+8 MoreParenteral Treprostinil - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of a medication called treprostinil on people with pulmonary arterial hypertension. The goal is to see if the medication can lower the pressure in the arteries of the lungs and improve the function of the right ventricle of the heart.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Baseline, Months 12, 24, and 36

Month 12
Number of Participants With Clinical Improvement From Baseline to Month 12, 24, and 36
Survival Rate: Number of Participants who Survived at Months 12, 24, and 36
Baseline, Month 12
Change From Baseline in RV End-Diastolic Volume Index at Month 12
Change From Baseline in RV Stroke Volume Index at Month 12
Change From Baseline in RV-Pulmonary Artery (PA) Coupling Estimated by the Ratio of Stroke Volume by End Systolic Volume at Month 12
Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12
Change From Baseline in mPAP at Month 12
Month 12
Change From Baseline in 6MWD at Month 12, 24, and 36
Change From Baseline in Borg Dyspnea Score at Months 12, 24, and 36
Change From Baseline in NT-proBNP at Months 12, 24, and 36
Change From Baseline in RV-PA Coupling Estimated by the Ratio of Tricuspid Annular Plane Systolic Excursion by Pulmonary Artery Systolic Pressure (TAPSE/PASP) at Months 12, 24, and 36
Change From Baseline in Registry to EValuate EArly and Long-Term PAH Disease Management (REVEAL) Lite 2 Risk Score at Months 12, 24, and 36
Change From Baseline in WHO FC at Months 12, 24, and 36
Month 24
Change From Baseline in mPAP at Months 24 and 36 (For Participants With Successful CardioMEMS™ PA Sensor Implant Only)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Treprostinil
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Treprostinil · No Placebo Group · Phase 4

TreprostinilExperimental Group · 2 Interventions: Parenteral Treprostinil, Oral Treprostinil · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Treprostinil
2007
Completed Phase 3
~900

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, months 12, 24, and 36

Who is running the clinical trial?

United TherapeuticsLead Sponsor
106 Previous Clinical Trials
12,227 Total Patients Enrolled
58 Trials studying Pulmonary Arterial Hypertension
8,177 Patients Enrolled for Pulmonary Arterial Hypertension
Lung Biotechnology PBCIndustry Sponsor
13 Previous Clinical Trials
681 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
533 Patients Enrolled for Pulmonary Arterial Hypertension

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Is recruitment for this clinical research still available?

"Correct. According to information available on clinicaltrials.gov, this medical study is actively recruiting for 50 patients from 2 sites as of October 27th 2022; the trial was initially posted 8/10/2022." - Anonymous Online Contributor

Unverified Answer

Has Treprostinil been green-lit by the FDA?

"There is sufficient clinical data to support treprostinil's safety, granting it a rating of 3." - Anonymous Online Contributor

Unverified Answer

How many participants are engaging in this research project?

"Affirmative. Clinicaltrials.gov discloses that the research study, which was posted on August 10th 2022 is still recruiting participants. 50 volunteers are needed for this trial between 2 selected medical facilities." - Anonymous Online Contributor

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