Clinical Trial

Safety and Efficacy Trial of HG004 for Leber Congenital Amaurosis Related to Rpe65 Gene Mutations (STAR)

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated September 19, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of the study is to determine whether HG004 as gene therapy is safe and effective for the treatment of Leber Congenital Amaurosis caused by mutations in RPE65 gene.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-06-13; most recent amendment 2024-09-13.
Status change: Not Yet Recruiting → Recruiting 2023-10-26
Trial Details
NCT Number NCT05906953
Lead Sponsor HuidaGene Therapeutics Co., Ltd.
Conditions Leber Congenital Amaurosis, Inherited Retinal Diseases Caused by RPE65 Mutations
Enrollment 20 participants
Start Date 2023-10-31
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-09-19