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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

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Conditions

Leukocyte Adhesion Deficiency

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States