Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06432140 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 21, 2026 (before its estimated July 23, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Phase changed: Phase 3 → Phase 2/3
    • Primary completion date: Jul 21, 2026 to Jul 23, 2026
    v6
  2. Phase: Phase 1 to Phase 3v5 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 16 to confirmed 13
    • Study sites: 0 to 1
    • Primary completion date: Jun 2026 to Jul 21, 2026
    • Study completion date: Sep 2030 to Sep 20, 2030
    • Start date changed from estimate of May 2024 to Jul 2, 2024
  3. Secondary endpoints: details revised at 1 of 7 entriesv4
  4. Primary endpoints revised (2)
    • Secondary endpoints revised (7)
    v3
  5. Secondary endpoints revised (7)
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 3 words
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This trial includes dose-escalating part (phase 1) and dose confirming part, to prove the safety and efficacy of VGN-R09b to treat patients with severe AADC deficiency
Trial Details
NCT Number NCT06432140
Lead Sponsor Shanghai Vitalgen BioPharma Co., Ltd.
Conditions
(from sponsor)		 Aromatic L-amino Acid Decarboxylase Deficiency
Related terms Aromatic amino acid decarboxylase deficiency
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov