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NCT04046224 · ClinicalTrials.gov registry record · Phase 1
Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR)
A Phase 1 study, sponsored by Sangamo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04046224 is a Phase 1 study that has completed, run by Sangamo Therapeutics. The registered enrollment target is 36 participants.
The verdict
NCT04046224, a Phase 1 study, has completed, sponsored by Sangamo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is the first in human treatment with ST-920, an adeno-associated virus (AAV2/6) vector encoding the complementary deoxyribonucleic acid (cDNA) for human a-Gal A. The purpose of this study is to evaluate the safety and tolerability of ascending doses of ST-920. ST-920 aims to provide stable, long-term production of α-Gal A at therapeutic levels in subjects with Fabry disease. The constant production of α-Gal A in humans should, importantly, enable reduction and potentially clearance of Fabry disease substrates Gb3 and lyso-Gb3. On Day 1, patients will be infused intravenously with a single dose of ST-920 and followed for a period of 52 weeks.
Interventions
- BIOLOGICAL ST-920
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2025-04-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04046224
The ClinicalTrials.gov registry entry for NCT04046224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sangamo Therapeutics, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ST-920 is the first listed.
NCT04046224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04046224 about?
NCT04046224 is a clinical study titled "Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR)". This is the first in human treatment with ST-920, an adeno-associated virus (AAV2/6) vector encoding the complementary deoxyribonucleic acid (cDNA) for human a-Gal A. The purpose of this study is to evaluate the safety and tolerability of ascending doses of ST-920. ST-920 aims to provide stable, lon...
What is the current status of trial NCT04046224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-07-23. Estimated completion is 2025-04-10.
What interventions are being tested in trial NCT04046224?
The interventions under investigation include: ST-920 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04046224?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
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