Pulmonary Arterial HypertensionNCT06603285
A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin
An observational study of Pulmonary Arterial Hypertension, run by Excelsior.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Treprostinil
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center, Prospective Study to Observe the Safety, Tolerability, and Efficacy of Remodulin® in Patients With Pulmonary Arterial Hypertension
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.
Read the detailed description
This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The expected study period will be 2 years. PAH patients, who met NHI criteria, to receive treprostinil subcutaneously/ intravenously, will be invited to join this study for observation. The dosage and administration schedule of study medication will be judged by investigators. If the eligibility criteria have been met and the subject have signed the informed consent, the subjects will be enrolled into this study. There will be 10 visits: Visit 1 (Screening visit, Week -2 ~ -1), Visit 2 (Week 1, initial of use treprostinil), Visit 3 to 9 (Week 13 to 85), Visit 10 (Week 97). The Day 1 in Week 1 should be the start day of treprostinil treatment. Subjects will be returned to the clinics every 3 months (i.e. 12 weeks) after Visit 2. The NT-proBNP level, WHO functional class, 6-minute walk distance, echocardiography, pulse oximetry, modified Borg Dyspnea Scale, SF-36 questionnaire, and dosage regimens of treprostinil (including dose adjustment) will be collected. For time to clinical worsening and death, it will be followed up during study period. All intercurrent events within 24 months will be recorded. Safety information, including vital signs, and physical exams will be checked. Adverse events of special interest (AESIs) will be reviewed every visit by using a predesignated AESI checklist.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Treprostinil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreprostinilDrug
Also called Remodulin
sc/iv continuously
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NT-proBNP
Calculate the \"N terminal pro B type natriuretic peptide\" change from baseline to Week 97
Measured: 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.
Measured: Week 97
Secondary outcomes (12)
Time to clinical worsening and death
Record the time to clinical worsening and death
Measured: 96 weeks
Change from baseline in NT-proBNP
Calculate the change from baseline in NT-proBNP at Week 13, 25, 37, 49, 61, 73, and 85
Measured: Week 13, 25, 37, 49, 61, 73, and 85
Change from baseline in 6-minute walk distance (6MWD)
Calculate the cange from baseline in 6-minute walk distance (6MWD) at Week 25, 49, 73, and 97
Measured: Week 25, 49, 73, and 97
Trend of dose usage from initiation treatment to clinical worsening
Record all the daily doses which the patients administered during the whole study period
Measured: 96 weeks
Adverse events of special interest (AESIs)
AESIs include infusion site pain, infusion site reaction, headache, diarrhea, nausea, rash, jaw pain, hot flashes, vasodilation, and edema
Measured: 96 weeks
Change from baseline in WHO functional class
Calculate the change from baseline in WHO functional class at Week 13, 25, 37, 49, 61, 73, and 85 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.
Measured: Week 13, 25, 37, 49, 61, 73, and 85
Change from baseline in right atrium (RA) area
RV structure and function will be monitored by echocardiography, including Right atrium (RA) area.
Measured: Week 25, 49, 73, and 97
Change from baseline in TAPSE/sPAP ratio.
RV structure and function will be monitored by echocardiography, including Tricuspid annular plane systolic excursion (TAPSE) / systolic pulmonary artery pressure (sPAP) ratio.
Measured: Week 25, 49, 73, and 97
Change from baseline in Pericardial effusion.
RV structure and function will be monitored by echocardiography, including Pericardial effusion.
Measured: Week 25, 49, 73, and 97
Change from baseline in modified Borg Dyspnea Scale
Calculate the change from baseline in modified Borg Dyspnea Scale at Week 25, 49, 73, and 97.
The modified Borg Dyspnea scales are patient self-reported measures of one's difficulty in breathing upon exertion. The Scale is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea.
Measured: Week 25, 49, 73, and 97
Change from baseline in SF-36 questionnaire
Calculate the change from baseline in SF-36 questionnaire at Week 25, 49, 73, and 97.
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.
It comprises 36 questions that cover eight domains of health. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
Measured: Week 25, 49, 73, and 97
Intercurrent event
Intercurrent events includes consent withdrawn, use of rescue medication, discontinuation from treprostinil treatment, PAH unrelated hospitalization, switch to other PAH drugs (other than treprostinil), add-on PAH drugs, or new-onset co-morbidity.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Oct 2025 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excelsior
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603285
- Sponsor's protocol ID
- EB057-PMS-01
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective Study to Observe the Safety, Tolerability, and Efficacy of Remodulin® in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06603285
- Acronym / sponsor ID
- EB057-PMS-01
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ExcelsiorIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The expected study period will be 2 years. PAH patients, who met NHI criteria, to receive treprostinil subcutaneously/ intravenously, will be invited to join this study for observation. The dosage and administration schedule of study medication will be judged by investigators. If the eligibility criteria have been met and the subject have signed the informed consent, the subjects will be enrolled into this study. There will be 10 visits: Visit 1 (Screening visit, Week -2 ~ -1), Visit 2 (Week 1, initial of use treprostinil), Visit 3 to 9 (Week 13 to 85), Visit 10 (Week 97). The Day 1 in Week 1 should be the start day of treprostinil treatment. Subjects will be returned to the clinics every 3 months (i.e. 12 weeks) after Visit 2. The NT-proBNP level, WHO functional class, 6-minute walk distance, echocardiography, pulse oximetry, modified Borg Dyspnea Scale, SF-36 questionnaire, and dosage regimens of treprostinil (including dose adjustment) will be collected. For time to clinical worsening and death, it will be followed up during study period. All intercurrent events within 24 months will be recorded. Safety information, including vital signs, and physical exams will be checked. Adverse events of special interest (AESIs) will be reviewed every visit by using a predesignated AESI checklist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreprostinilAlso: Remodulinsc/iv continuously | Drug | – |
Primary outcome
Change from baseline in NT-proBNP
Time frame: Week 97
Calculate the \"N terminal pro B type natriuretic peptide\" change from baseline to Week 97
Change from baseline in WHO functional class
Time frame: Week 97
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.
12 secondary outcomes
Time to clinical worsening and death
Time frame: 96 weeks
Change from baseline in NT-proBNP
Time frame: Week 13, 25, 37, 49, 61, 73, and 85
Change from baseline in 6-minute walk distance (6MWD)
Time frame: Week 25, 49, 73, and 97
Trend of dose usage from initiation treatment to clinical worsening
Time frame: 96 weeks
Adverse events of special interest (AESIs)
Time frame: 96 weeks
Change from baseline in WHO functional class
Time frame: Week 13, 25, 37, 49, 61, 73, and 85
Change from baseline in right atrium (RA) area
Time frame: Week 25, 49, 73, and 97
Change from baseline in TAPSE/sPAP ratio.
Time frame: Week 25, 49, 73, and 97
Change from baseline in Pericardial effusion.
Time frame: Week 25, 49, 73, and 97
Change from baseline in modified Borg Dyspnea Scale
Time frame: Week 25, 49, 73, and 97
Change from baseline in SF-36 questionnaire
Time frame: Week 25, 49, 73, and 97
Intercurrent event
Time frame: 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Excelsior.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cliff Lin (+886226557568 ext. 1421, cliff.lin@excelsiorgroup.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in NT-proBNP (time frame: Week 97). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.