clinical trial · NCT06805695
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
iECURE, Inc.·—·recruiting·n = 13
Ornithine Transcarbamylase DeficiencyOrnithine Transcarbamylase Deficiency DiseaseUrea Cycle Disorders, InbornNo Intervention
brief summary
This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also participated in a parent protocol.
started
Dec 23, 2024
primary completion
Jul 1, 2041
completion
Jul 1, 2041
last updated
Feb 3, 2025
detailed description
This is a 14.5 year LTFU protocol to assess long term safety and clinical response to IP as well as to capture natural disease history of participants not dosed with IP in a parent protocol. No IP is provided as part of this protocol. Participants will remain on standard of care medication as indicated and prescribed by their physicians.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol