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NCT05906953 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Trial of HG004 for Leber Congenital Amaurosis Related to Rpe65 Gene Mutations (STAR)
A Phase 1 study of Leber Congenital Amaurosis and Inherited Retinal Diseases Caused by RPE65 Mutations, sponsored by HuidaGene Therapeutics Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT05906953 is a Phase 1 study of Leber Congenital Amaurosis and Inherited Retinal Diseases Caused by RPE65 Mutations that is actively recruiting participants, run by HuidaGene Therapeutics Co.. The registered enrollment target is 20 participants, below the 25-participant average among 6 other Leber Congenital Amaurosis trials with a reported enrollment target (20% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05906953, a Phase 1 study of Leber Congenital Amaurosis and Inherited Retinal Diseases Caused by RPE65 Mutations, is actively recruiting participants, sponsored by HuidaGene Therapeutics Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG HG004
Study Locations (3)
California
- Research Site - Sacramento
Texas
- Research Site - Houston
Shanghai Municipality
- Research Site - Shanghai
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05906953
The ClinicalTrials.gov registry entry for NCT05906953 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 25-participant average among 6 other Leber Congenital Amaurosis trials with a reported enrollment target (20% lower). The listed sponsor is HuidaGene Therapeutics Co., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Leber Congenital Amaurosis appearing as the primary indexed condition, and to 1 intervention - of which HG004 is the first listed.
NCT05906953 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Texas, Shanghai Municipality.
Frequently Asked Questions
What is clinical trial NCT05906953 about?
NCT05906953 is a clinical study titled "Safety and Efficacy Trial of HG004 for Leber Congenital Amaurosis Related to Rpe65 Gene Mutations (STAR)". 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.
What is the current status of trial NCT05906953?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-10-31. Estimated completion is 2025-12.
What conditions does trial NCT05906953 study?
This clinical trial studies the following conditions: Leber Congenital Amaurosis, Inherited Retinal Diseases Caused by RPE65 Mutations.
What interventions are being tested in trial NCT05906953?
The interventions under investigation include: HG004 (DRUG).
Who is sponsoring clinical trial NCT05906953?
This trial is sponsored by HuidaGene Therapeutics Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05906953 being conducted?
This trial has 3 study locations across California, Texas, Shanghai Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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