A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treprostinil.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Prospective Study to Observe the Safety, Tolerability, and Efficacy of Remodulin® in Patients With Pulmonary Arterial Hypertension
Overview
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.
Interventions
- Drug Treprostinil
sc/iv continuously
Primary outcome measures
- Change from baseline in NT-proBNP [Time frame: Week 97]
- Change from baseline in WHO functional class [Time frame: Week 97]
Secondary outcome measures (12)
- 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]
Eligibility 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
- Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06603285 · EB057-PMS-01