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Recruiting Phase 3 NCT05754450
An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II
Trial Parameters
Condition Leukocyte Adhesion Deficiency
Sponsor AUG Therapeutics
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 2
Sex ALL
Min Age 6 Months
Max Age 75 Years
Start Date 2023-04-10
Completion 2024-12-31
Interventions
AVTX-803
Brief 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
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