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Phase 1 Follow-on Study of AAV2-hRPE65v2 Vector in Subjects With Leber Congenital Amaurosis (LCA) 2

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Mar 2030 to Oct 2027
    • Study completion date: Jun 2030 to Oct 2027
    v20
  2. 3 versions Re-verified since Jul 15, 2022, no change to tracked fieldsv17-v19
  3. Primary completion date: Nov 2026 to Mar 2030
    • Study completion date: Nov 2026 to Jun 2030
    v16
  4. Re-verified, no change to tracked fieldsv15
  5. Interventions: AAV2-hRPE65v2 (Biological) to voretigene neparvovec-rzyl (Biological)
    • Study description expanded, about 3 words
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. 4 versions Re-verified since Feb 2, 2015, no change to tracked fieldsv10-v13
  2. Lead sponsor: Children's Hospital of Philadelphia to Spark Therapeutics, Inc.
    • Publications: 5 to 6
    v9
  3. 2 versions Re-verified since Apr 5, 2013, no change to tracked fieldsv7-v8
  4. Study arms: 0 to 1v6
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  6. 2 versions Re-verified since May 6, 2011, no change to tracked fieldsv3-v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a follow-on to a Phase 1 dose-escalation and safety study.
Trial Details
NCT Number NCT01208389
Lead Sponsor Spark Therapeutics, Inc.
Conditions
(from sponsor)		 Leber Congenital Amaurosis
Related terms Leber Congenital Amaurosis
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov