Tokyo, Dec. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060071) titled 'A multicenter observational study on the efficacy and safety of selexipag in pediatric pulmonary arterial hypertension' on Dec. 12.
Study Type:
Observational
Primary Sponsor:
Institute - Toho University
Condition:
Condition - Pediatric pulmonary arterial hypertension
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to clarify the real-world outcomes of selexipag in pediatric patients with pulmonary arterial hypertension (PAH) and to explore the association between plasma drug concentration and treatment response.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 2
years-old
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following inclusion criteria
1. Patients aged 2 years or older but younger than 15 years
2. Patients who have undergone cardiac catheterization and have been diagnosed with pulmonary arterial hypertension
3. Patients who are newly initiated on selexipag therapy following its regulatory approval
Key exclusion criteria - Patients who meet at least one of the following criteria
1. Patients scheduled to undergo surgical repair during the observation period
2. Patients with Fontan circulation
Target Size - 30
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 01 Month 22 Day
Date of IRB - 2025 Year 05 Month 19 Day
Anticipated trial start date - 2025 Year 05 Month 21 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068698
Disclaimer: Curated by HT Syndication.
