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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 (NPC)

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 34 sites
  2. Site contacts updated at 1 of 34 sites
  3. Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 21 entries
    • Site details revised at 9 of 34 sites
  4. Study sites revised (34)v29
  5. Site details revised at 1 of 34 sitesv28
Show 2 earlier versionsHide 2 earlier versions
  1. Site details revised at 1 of 34 sitesv27
  2. Study sites: 35 to 34v26
  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 35 sites
    v25
  2. Primary completion date: Nov 4, 2027 to May 14, 2028
    • Study completion date: Nov 4, 2027 to Jun 14, 2028
    v24
  3. Site details revised at 1 of 35 sitesv23
  4. Study sites: 34 to 35v22
  5. Sponsor changed: Azafaros A.G. to Azafaros B.V.
    • Site details revised at 1 of 34 sites
    v21
  6. Site details revised at 1 of 34 sitesv20
  7. Site details revised at 2 of 34 sitesv19
  8. Site details revised at 1 of 34 sitesv18
  9. Site details revised at 1 of 34 sitesv17
  10. Study sites: 33 to 34v16
  11. Site details revised at 4 of 33 sitesv15
  12. Site details revised at 2 of 33 sitesv14
  13. Study sites: 30 to 33v13
  14. Site contacts updated at 1 of 30 sitesv12
  15. Site details revised at 1 of 30 sitesv11
  16. Site details revised at 1 of 30 sitesv10
  17. Site details revised at 6 of 30 sitesv9
  18. Site contacts updated at 8 of 30 sitesv8
  19. Site details revised at 2 of 30 sitesv7
  20. Study sites: 31 to 30v6
  21. Study sites: 27 to 31v5
  22. Site details revised at 2 of 27 sitesv4
  23. Re-verified, no change to tracked fieldsv3
  24. Site details revised at 8 of 27 sitesv2
  25. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Trial Details
NCT Number NCT07082725
Lead Sponsor Azafaros B.V.
Conditions
(from sponsor)		 Niemann-Pick Type C Disease
Related terms Niemann-Pick Disease, Type C
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov