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Clinical Trials List

Protocol NumberEB057-PMS-01

NCT Number(ClinicalTrials.gov Identfier)NCT06603285

Active

2024-08-01 - 2028-12-31

Others

Recruiting9

ICD-10I27.0

Primary pulmonary hypertension

ICD-9416.0

Primary pulmonary hypertension

A multi-center, prospective study to observe the safety, tolerability, and efficacy of Remodulin® in patients with pulmonary arterial hypertension

Trial Applicant

EXCELSIOR BIOPHARMA INCORPORATION
Sponsor

EXCELSIOR BIOPHARMA INCORPORATION
Trial scale

Taiwan Multiple Center
Update

2026/09/14

Investigators and Locations

Principal Investigator 吳懿哲 Division of Cardiovascular Diseases

MacKay Memorial Hospital

Co-Principal Investigator

吳書豪 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林坤璋 Division of Cardiovascular Diseases

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

黃偉春 Division of Cardiovascular Diseases
郭書宏 Division of Cardiovascular Diseases
楊弘州 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃祺耀 Division of Cardiovascular Diseases

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kuo-Yang Wang Division of Cardiovascular Diseases

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsin Hsu Division of Cardiovascular Diseases

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

屏基醫療財團法人屏東基督教醫院及其瑞光院區

Co-Principal Investigator

黃偉春 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung Division of Cardiovascular Diseases

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭錦昌 Division of Cardiovascular Diseases

屏東榮民總醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Jing Ho

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Arterial Hypertension

Objectives

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.

Test Drug

Remodulin

Active Ingredient

2012600600

Dosage Form

Drug substance solution

Dosage

001

Endpoints

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

Inclution Criteria

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

Exclusion Criteria

Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil

The Estimated Number of Participants

Taiwan

20 participants
Global

20 participants