RecruitingPhase 3NCT05754450
An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II
A Phase 3, Open-Label, Extension Study to Assess the Long-term Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II (LAD II)
Sponsor
AUG Therapeutics
Enrollment
2 participants
Start Date
Apr 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The primary objective of this extension study is to assess the long-term safety and efficacy of AVTX-803 in subjects with LAD II (SLC35C1-CDG).
Eligibility
Min Age: 6 MonthsMax Age: 75 Years
Inclusion Criteria2
- Subject must have completed protocol AVTX-803-LAD-301
- Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
Exclusion Criteria4
- Subject has severe anemia defined as hemoglobin <8.0 g/dL (<4.9 mmol/L)
- Subject has impaired renal function as defined by an eGFR <90 mL/min
- Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product
- In the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGAVTX-803
L-fucose crystalline powder
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05754450