A PHASE 3 OPEN-LABEL STUDY OF PTC923 (SEPIAPTERIN) IN PHENYLKETONURIA

• Research type

  Research Study

• Full title

  A PHASE 3 OPEN-LABEL STUDY OF PTC923 (SEPIAPTERIN) IN PHENYLKETONURIA

• IRAS ID

  1005744

• Contact name

  Allison Fortenberry

• Contact email

  medinfo@ptcbio.com

• Sponsor organisation

  PTC Therapeutics, Inc.

• Eudract number

  2021-000497-28

• Clinicaltrials.gov Identifier

  NCT05166161

• Research summary

  A Phase 3 Extension Study of PTC923 in Subjects with Phenylketonuria (PKU). PKU is a rare inherited disorder that causes an amino acid called phenylalanine to build up in the body when protein is eaten.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  22/LO/0485

• Date of REC Opinion

  18 Aug 2022

• REC opinion

  Further Information Favourable Opinion