A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin

NCT06603285 | Not Yet Recruiting

• 1 other identifier: EB057-PMS-01
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The objective in this study is to observe the efficacy and safety of treprostinil in subjects with pulmonary arterial hypertension.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• Change from baseline in NT-proBNP

  Calculate the \"N terminal pro B type natriuretic peptide\" change from baseline to Week 97

  Week 97

• Change from baseline in WHO functional class

  Calculate the World Health Organization functional class change from baseline to Week 97. The World Health Organization (WHO) functional class describes how severe a patient\'s pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV is the most severe form of PH.

  Week 97

Secondary Outcomes (12)

• Time to clinical worsening and death

  96 weeks

• Change from baseline in NT-proBNP

  Week 13, 25, 37, 49, 61, 73, and 85

• Change from baseline in 6-minute walk distance (6MWD)

  Week 25, 49, 73, and 97

• Trend of dose usage from initiation treatment to clinical worsening

  96 weeks

• Adverse events of special interest (AESIs)

  96 weeks

Interventions

Treprostinil DRUG

sc/iv continuously

Also known as: Remodulin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients who were diagnosed with symptomatic idiopathic or heritable PAH classified as WHO functional class III and IV symptoms and met NHI criteria, will be scheduled to receive subcutaneous/intravenous treprostinil treatment

You may qualify if:

• Diagnosed with symptomatic idiopathic or heritable PAH classified as WHO functional class III and IV symptoms.
• PAH patient, who met NHI criteria, will be scheduled to receive subcutaneous/intravenous treprostinil treatment.
• Ability to adhere to the study visit schedule and understand and comply with all protocol requirements.
• Will provide completed and signed written informed consents

You may not qualify if:

• Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil

Sponsors & Collaborators

• Excelsior: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Cliff Lin

CONTACT

+886226557568; cliff.lin@excelsiorgroup.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: September 19, 2024
• Study Start: October 16, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share