Extension Study of AVTX-803 for Leukocyte Adhesion Deficiency Type II

This study is looking at the long-term safety and effectiveness of AVTX-803, a crystalline powder form of L-fucose, for people with Leukocyte Adhesion Deficiency Type II (LAD II), also known as SLC35C1-CDG. To join, you must have already completed a previous study (AVTX-803-LAD-301) and have a confirmed diagnosis of LAD II. The study will measure side effects related to AVTX-803 over about one year to see how safe it is. We don't have information on the current recruitment status, but the study plans to enroll 2 participants between 6 months and 75 years old.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is an extension study, suggesting it follows a previous trial, and plans to enroll 2 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about one year to track any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05754450

An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II

Recruiting
PHASE3Ages 6–75InterventionalTreatment
AUG Therapeutics
~2 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:AVTX-803

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment emergent adverse events reported during the study attributable to AVTX-803.
Measured over Through study completion, an average of 1 year.
Leukocyte Adhesion Deficiency

NCT05754450

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • David Deyle · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Subject must have completed protocol AVTX-803-LAD-301
Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

Exclusion

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
  • Incidence of treatment emergent adverse events reported during the study attributable to AVTX-803.Through study completion, an average of 1 year.