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A Study of AAV9 Gene Therapy in Participants With Canavan Disease (CANaspire Clinical Trial)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 17, 2026 (before its estimated October 13, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date: Oct 8, 2030 to Oct 8, 2032
    • Site contacts updated at 3 of 4 sites
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Eligibility criteria expanded, about 11 words
    • Site contacts updated at 1 of 4 sites
    • Study title expanded, about 3 words
    v12
  4. Primary completion date: Oct 15, 2024 to Oct 13, 2026
    • Enrollment target: 18 to 26
    • Study completion date: Mar 15, 2028 to Oct 8, 2030
    • Site details revised at 3 of 4 sites
    v11
  5. Site contacts updated at 2 of 4 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 1 of 4 sitesv9
  2. Study sites: 3 to 4v8
  3. Site details revised at 1 of 3 sitesv7
  4. Study sites: 1 to 3
    • Primary completion date: Oct 31, 2024 to Oct 15, 2024
    • Study completion date: Oct 31, 2028 to Mar 15, 2028
    • Primary endpoints revised (3)
    v6
  5. 2 versions Re-verified since Mar 12, 2022, no change to tracked fieldsv4-v5
  6. Start date changed from estimate of Oct 31, 2021 to Sep 8, 2021v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 7 words
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 main objective of this trial is to evaluate the safety, tolerability, and pharmacodynamic activity of BBP-812, an investigational AAV9-based gene therapy, in pediatric participants with Canavan disease.
Trial Details
NCT Number NCT04998396
Lead Sponsor Aspa Therapeutics
Conditions
(from sponsor)		 Canavan Disease
Related terms Canavan Disease, Leukoencephalopathies, Rare Diseases
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov