Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05270837 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria

Study acronym: PEGASUS
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results first posted: Jul 21, 2026v19
  2. Primary endpoints revised (8)
    • Secondary endpoints: 6 to 9
    v18
  3. Primary endpoints: 2 to 8
    • Secondary endpoints: 1 to 6
    v17
  4. Re-verified, no change to tracked fieldsv16
  5. Primary completion date changed from estimate of Jan 2025 to Jan 14, 2025v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 17 to 16v14
  2. Study sites: 18 to 17
    • Primary completion date: Dec 2025 to Jan 2025
    • Study completion date: Dec 2025 to Oct 2027
    v13
  3. Re-verified, no change to tracked fieldsv12
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 54 to 55
    • Study sites: 19 to 18
    v11
  5. Study sites: 21 to 19v10
  6. Site contacts updated at 9 of 21 sitesv9
  7. Site details revised at 6 of 21 sitesv8
  8. Site details revised at 6 of 21 sitesv7
  9. Site details revised at 3 of 21 sitesv6
  10. Site contacts updated at 2 of 21 sitesv5
  11. Study sites: 19 to 21v4
  12. Study sites: 17 to 19
    • Start date changed from estimate of Jun 2022 to Jun 17, 2022
    v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2022 to Jun 2022
    • Study sites: 12 to 17
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 3 open-label randomized controlled study enrolling approximately 54 adolescents with PKU. The study is designed to assess the safety and efficacy of pegvaliase injections.
Trial Details
NCT Number NCT05270837
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Phenylketonuria (PKU)
Related terms Phenylketonurias
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov