NCT05754450PHASE3Recruiting
An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II
AUG Therapeutics
Start Date
4/10/2023
Completion Date
12/31/2026
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 Criteria
Age Range: No minimum to 75 years
Inclusion Criteria:
* Subject must have completed protocol AVTX-803-LAD-301
* Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
Exclusion Criteria:
* 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
Interventions
DRUG
AVTX-803
Conditions
Leukocyte Adhesion Deficiency
Locations
Mayo Clinic
Rochester, Minnesota 55905
United States