Status:
UNKNOWN
AT-007 in Adult Subjects With Classic Galactosemia (CG)
Lead Sponsor:
Applied Therapeutics, Inc.
Conditions:
Classic Galactosemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is a 12-month open-label extension (OLE) study of AT-007 in adult subjects with CG who previously participated in Study AT-007-1001 Part D and/or Part D Extension. The study is designed to...
Detailed Description
Primary: \- To evaluate the long-term safety of 12-month oral administration of AT-007 in adult subjects with Classic Galactosemia (CG) Secondary: * To evaluate the long-term inhibition of galactit...
Eligibility Criteria
Inclusion
- Male or non-pregnant, non-lactating female subject with a CG diagnosis
- Previous participation in Study AT-007-1001 Part D and/or Part D Extension
- No other significant health problems which preclude participation
Exclusion
- Concomitant use of certain medications or over-the-counter therapies
- Discontinuation from Study AT-007-1001 Part D and/or Part D Extension due an adverse event
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05418829
Start Date
October 1 2021
End Date
December 1 2022
Last Update
June 14 2022
Active Locations (1)
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1
Hassman Research Institute
Berlin, New Jersey, United States, 08009