Clinical Trial: Safety, Adverse Events, and Pharmacokinetics/Therapeutic Drug Monitoring of Sirolimus in Infants Under One Year of Age: A Scoping Review (Japan)

Tokyo, Sept. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063067) titled 'Safety, Adverse Events, and Pharmacokinetics/Therapeutic Drug Monitoring of Sirolimus in Infants Under One Year of Age: A Scoping Review' on Sept. 28.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Nagoya City University

Condition: Condition - Diseases requiring sirolimus administration in infants under 1 year of age (e.g., vascular malformations, tuberous sclerosis, lymphatic anomalies) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To conduct a scoping review of existing literature to comprehensively evaluate the safety, adverse events, tolerability, dosage, pharmacokinetic (PK) parameters, and therapeutic drug monitoring (TDM) data of sirolimus in infants under 1 year of age (including preterm and newborn infants). Basic objectives2 - Others

Eligibility: Age-lower limit - 1 days-old

Gender - Male and Female Key inclusion criteria - 1 Infants under 1 year of age (including preterm and newborn infants). For studies targeting a broader pediatric population, only those with extractable individual data for infants under 1 year are included. 2 Administration of sirolimus (rapamycin) with evaluation of safety, adverse events (AEs), tolerability, dosage, pharmacokinetic (PK) parameters, or therapeutic drug monitoring (TDM) data (e.g., trough levels). 3 Any clinical setting regardless of underlying condition or indication (e.g., vascular malformations, tuberous sclerosis, lymphatic anomalies, off-label use). 4 Study designs: Case reports, case series, observational studies, non-randomized interventional studies, and randomized controlled trials (RCTs). Key exclusion criteria - 1 Preclinical studies (animal models and in vitro experiments). 2 Review articles without primary data. 3 Conference abstracts without available full text. Target Size - 0

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 08 Month 28 Day Date of IRB - 2026 Year 09 Month 28 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072196

Disclaimer: Curated by HT Syndication.