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Clinical Trials List

Protocol NumberEB057-PMS-01
NCT Number(ClinicalTrials.gov Identfier)NCT06603285
Active

2024-08-01 - 2029-12-31

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

  • Trial scale

    Taiwan Multiple Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 吳懿哲 Division of Cardiovascular Diseases

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

Co-Principal Investigator

  • 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 Kuo-Yang Wang Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsin Hsu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃祺耀 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Jing Ho Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭錦昌 Division of Cardiovascular Diseases

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Arterial Hypertension

Objectives

The purpose of this trial was to evaluate the safety, tolerability, and efficacy of remodulin in patients with pulmonary hypertension.

Test Drug

原料藥溶液劑

Active Ingredient

Treprostinil Sodium

Dosage Form

070

Dosage

MG

Endpoints

1. Changes in WHO functional classification from baseline values

[Timeline: Week 97]

2. Changes in NT-proBNP concentration from baseline values

[Timeline: Week 97]

Inclution Criteria

Inclusion 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

Exclusion Criteria:

Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    20 participants