Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062683) titled 'Study of Safe Use of Clazosentan in Patients with Aneurysmal Subarachnoid Hemorrhage' on Aug. 25.
Study Type:
Observational
Primary Sponsor:
Institute - University of Shizuoka
Condition:
Condition - Subarachnoid hemorrhage
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - To clarify the association between OATP activity and interindividual variability in clazosentan pharmacokinetics, and to investigate the association between pharmacokinetic variability and fluid retention-related adverse events.
Basic objectives2 - Pharmacokinetics
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients with subarachnoid hemorrhage due to a ruptured brain aneurysm who underwent surgery and were newly initiated on clazosentan therapy at the Department of Neurosurgery, Shizuoka General Hospital.
2.Patients (or their legally acceptable representatives/surrogates) who have provided written informed consent to participate in this study.
Key exclusion criteria - 1.Pregnant women or women who may be pregnant
2.Patients with ongoing intracranial hemorrhage
3.Patients with severe hepatic impairment (Child-Pugh Class C)
4.Patients who have received rifampicin within the past 14 days or are currently receiving rifampicin
Target Size - 60
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 04 Month 17 Day
Date of IRB - 2026 Year 06 Month 18 Day
Anticipated trial start date - 2026 Year 08 Month 25 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071770
Disclaimer: Curated by HT Syndication.
