clinical trial · NCT05166161
A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria
PhenylketonuriaPTC923
brief summary
The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.
started
Feb 14, 2022
primary completion
Jun 30, 2026
completion
Jun 30, 2026
last updated
Apr 24, 2026
detailed description
Eligible participants are:
Feeder participants: those who have completed a Phase 3 PTC Therapeutics (PTC) sponsored feeder study.
Non-feeder controlled participants: those who have not completed a feeder study and have blood Phe levels \<360 μmol/L at study entry.
Non-feeder uncontrolled participants: those who have not completed a feeder study and have blood Phe levels ≥360 μmol/L at study entry.
official title
A Phase 3 Open-Label Study of PTC923 (Sepiapterin) in Phenylketonuria
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol