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An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 3 of 8 entries
    • Site details revised at 11 of 30 sites
  2. Primary and study completion moved earlier from Jun 30, 2028 to Oct 28, 2026
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    v39
  3. Re-verified, no change to tracked fieldsv38
  4. Primary and study completion moved earlier from Aug 31, 2028 to Jun 30, 2028v37
  5. 4 versions Re-verified since Jan 30, 2026, no change to tracked fieldsv33-v36
Show 31 earlier versionsHide 31 earlier versions
  1. Primary completion date: Jul 31, 2028 to Aug 31, 2028v32
  2. 15 versions Re-verified since Sep 5, 2024, no change to tracked fieldsv17-v31
  3. Primary completion date: Dec 31, 2024 to Jul 31, 2028
    • Study sites: 24 to 30
    • Study completion date: Dec 31, 2026 to Aug 31, 2028
    v16
  4. Lead sponsor: Albireo to Albireo, an Ipsen Companyv15
  5. 5 versions Re-verified since Jan 31, 2024, no change to tracked fieldsv10-v14
  6. Study sites: 22 to 24v9
  7. Study sites: 19 to 22v8
  8. Study sites: 10 to 19v7
  9. Study sites: 7 to 10v6
  10. Study sites: 4 to 7v5
  11. Study sites: 2 to 4v4
  12. Study sites: 1 to 2
    • Start date changed from estimate of Jul 1, 2022 to Jul 5, 2022
    v3
  13. Secondary endpoints: 9 to 8v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
Trial Details
NCT Number NCT05426733
Lead Sponsor Albireo, an Ipsen Company
Conditions
(from sponsor)		 Biliary Atresia
Related terms Biliary Atresia
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov