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A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

StatusRecruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Nov 2029 → Nov 30, 2030
See other at-risk trials from Ipsen

Record History

  1. Eligibility criteria expanded, about 7 words Secondary endpoints: details revised at 2 of 6 entries · Site details revised at 8 of 10 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised at 8 of 10 sites
  2. Re-verified, no change to tracked fieldsv19
  3. Primary and study completion pushed from Nov 2029 to Nov 30, 2030 Site details revised at 1 of 10 sitesv18 Show 1 more changeShow less
    • Site details revised at 1 of 10 sites
  4. Re-verified, no change to tracked fieldsv17
  5. Study sites: 9 to 10v16
Show 14 earlier versionsHide 14 earlier versions
  1. Re-verified, no change to tracked fieldsv15
  2. Study sites: 8 to 9v14
  3. Study sites: 3 to 8v13
  4. Study sites: 2 to 3v12
  5. 8 versions Re-verified since May 27, 2025, no change to tracked fieldsv4-v11
  6. Study sites: 1 to 2 Start date changed from estimate of Apr 14, 2025 to Apr 22, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Apr 14, 2025 to Apr 22, 2025
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Mar 17, 2025 to Apr 14, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Mar 17, 2025 to Apr 14, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Ipsen
46 trials monitored
See 4 trials at risk
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives. Odevixibat is a medicine that helps patients with ALGS, a rare disease that harms their liver and causes itching. The main aim of this study is to observe the long-term, everyday effectiveness and safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.
Trial Details
NCT Number NCT06850038
Lead Sponsor Ipsen
Conditions Alagille Syndrome
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov