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Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 7 of 16 entries
    • Site details revised at 11 of 35 sites
    • Study description expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv37
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment reduced: 70 → 62 participants
    • Trial sites reduced: 39 → 35 locations
    v36
  4. Site details revised at 5 of 39 sitesv35
  5. Trial sites expanded: 35 → 39 locationsv34
Show 32 earlier versionsHide 32 earlier versions
  1. Site details revised at 5 of 35 sitesv33
  2. Study sites: 34 to 35v32
  3. Study sites: 35 to 34v31
  4. Study sites revised (35)v30
  5. Re-verified, no change to tracked fieldsv29
  6. Primary and study completion dates: Apr 9, 2026 to Dec 31, 2026
    • Study sites: 33 to 35
    v28
  7. Study sites: 34 to 33v27
  8. Study sites: 30 to 34v26
  9. Study sites: 27 to 30v25
  10. Study sites: 26 to 27v24
  11. Re-verified, no change to tracked fieldsv23
  12. Study sites: 25 to 26v22
  13. Study sites: 24 to 25v21
  14. Study sites: 25 to 24v20
  15. Primary completion date: Oct 9, 2026 to Apr 9, 2026
    • Study completion date: Apr 16, 2027 to Apr 9, 2026
    • Study sites revised (25)
    v19
  16. Re-verified, no change to tracked fieldsv18
  17. Study sites: 24 to 25v17
  18. Study sites: 22 to 24v16
  19. 2 versions Re-verified since Aug 31, 2024, no change to tracked fieldsv14-v15
  20. Site details revised at 1 of 22 sitesv13
  21. Re-verified, no change to tracked fieldsv12
  22. Lead sponsor: Albireo to Albireo, an Ipsen Companyv11 Show 9 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Feb 7, 2024 to Oct 9, 2026
    • Primary endpoints: 1 to 7
    • Enrollment target: 50 to 70
    • Study sites: 21 to 22
    • Study completion date: Mar 31, 2025 to Apr 16, 2027
    • Eligibility criteria expanded, about 466 words
    • Secondary endpoints: 5 to 16
    • Study description expanded, about 211 words
  23. Re-verified, no change to tracked fieldsv10
  24. Study completion date: Mar 2025 to Mar 31, 2025v9
  25. Enrollment target: estimated 63 to confirmed 50
    • Study completion date: Mar 31, 2025 to Mar 2025
    v8
  26. 2 versions Re-verified since Jan 30, 2024, no change to tracked fieldsv6-v7
  27. Study sites: 20 to 21
    • Primary completion date: Feb 2024 to Feb 7, 2024
    • Study completion date: Mar 2024 to Mar 31, 2025
    v5
  28. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study sites: 8 to 20
    • Primary completion date: Oct 2023 to Feb 2024
    • Study completion date: Oct 2023 to Mar 2024
    v4
  29. Study sites: 2 to 8v3
  30. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2021 to Sep 3, 2021
    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.
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS). The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include blockage of the flow of bile from the liver (cholestasis), yellowing of the skin and mucous membranes (jaundice), poor weight gain and growth and severe itching (pruritis). The drug used for the study is odevixibat and was authorized for the treatment of cholestatic pruritus in infants with ALGS over 12 months of age by the United States Food and Drug Administration on 13 June 2023.
Trial Details
NCT Number NCT05035030
Lead Sponsor Albireo, an Ipsen Company
Conditions
(from sponsor)		 Alagille Syndrome
Related terms Alagille Syndrome
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov