Actively Recruiting
A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type II
Led by AUG Therapeutics · Updated on 2026-05-01
4
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the efficacy and safety of AVTX-803 compared to withdrawal in patients with Leukocyte Adhesion Deficiency, Type II (LAD II).
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 6 months and 75 years old
- Confirmed biochemical and genetic diagnosis of Leukocyte Adhesion Deficiency Type II (SLC35C1-CDG)
- Documented history of Lewis antigen deficiency
- History of recurrent infections, opportunistic infections, or infections not responding well to standard care
- Written informed consent provided by participant or guardian; assent provided by minors as appropriate
- Ability and willingness to follow study protocol
- Women of childbearing potential must be non-lactating, have a negative pregnancy test at screening, and use acceptable double-barrier contraception during the study and 30 days after last dose
- Male participants must agree to use acceptable double-barrier contraception during the study and 30 days after last dose
You will not qualify if you...
- Severe anemia with hemoglobin below 8.0 g/dL (4.9 mmol/L)
- Impaired kidney function with estimated glomerular filtration rate below 90 mL/min
- Total absence of fucosylation on red blood cells combined with presence of anti-H antigen
- Known or suspected allergy or intolerance to fucose or any ingredients of the study drug
- History of not responding to adequate dosing of fucose as judged by the investigator
- Inability or unwillingness to comply with study requirements as judged by the investigator
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Jennifer Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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