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A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease, GM1 Gangliosidosis or GM2 Gangliosidosis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Nov 4, 2027 → May 14, 2028
See other at-risk trials from Azafaros B.V.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 39 sites
  2. Study sites: 38 to 39
  3. Site details revised at 8 of 38 sites
    • Eligibility criteria expanded, about 4 words
  4. Study sites revised (38)v32
  5. Site details revised at 1 of 38 sitesv31
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 1 of 38 sitesv30
  2. Site details revised at 2 of 38 sitesv29
  3. Study description expanded, about 11 wordsv28
  1. Primary completion pushed from Nov 4, 2027 to May 14, 2028
    • Study completion pushed from Nov 4, 2027 to Jun 14, 2028
    • Site details revised at 1 of 38 sites
    v27
  2. Primary completion date: Nov 4, 2027 to May 14, 2028
    • Study completion date: Nov 4, 2027 to Jun 14, 2028
    v26
  3. Site details revised at 1 of 38 sitesv25
  4. Study sites: 37 to 38v24
  5. Sponsor changed: Azafaros A.G. to Azafaros B.V.
    • Site details revised at 1 of 37 sites
    v23
  6. Site details revised at 1 of 37 sitesv22
  7. Site details revised at 2 of 37 sitesv21
  8. Site details revised at 1 of 37 sitesv20
  9. Site details revised at 1 of 37 sitesv19
  10. Site details revised at 1 of 37 sitesv18
  11. Site details revised at 6 of 37 sitesv17
  12. Site details revised at 3 of 37 sitesv16
  13. Study sites: 34 to 37v15
  14. Site contacts updated at 1 of 34 sitesv14
  15. Site details revised at 1 of 34 sitesv13
  16. Site details revised at 1 of 34 sitesv12
  17. Site details revised at 6 of 34 sitesv11
  18. Site contacts updated at 9 of 34 sitesv10
  19. Site details revised at 2 of 34 sitesv9
  20. Study sites: 35 to 34v8
  21. Study sites: 32 to 35v7
  22. Site details revised at 3 of 32 sitesv6
  23. Site details revised at 1 of 32 sitesv5
  24. Site details revised at 8 of 32 sitesv4
  25. Eligibility criteria revised
    • Study description revised
    v3
  26. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 32 of 32 sites
    v2
  27. 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.
Azafaros B.V.
6 trials monitored
See 3 trials at risk
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease and in late-infantile and juvenile-onset forms of GM1 gangliosidosis or GM2 gangliosidosis
Trial Details
NCT Number NCT07054515
Lead Sponsor Azafaros B.V.
Conditions
(from sponsor)		 Niemann-Pick Type C Disease, GM1 Gangliosidosis, GM2 Gangliosidosis
Related terms Gangliosidoses, GM2, Gangliosidosis, GM1, Niemann-Pick Disease, Type C
Enrollment 147 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov