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

RecruitingPhase 3

A Phase 3, Open-Label, Extension Study to Assess the Long-term Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II (LAD II)

Who can join

6 Months – 75 Years · All sexes

Full 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

About the study

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).

What is being tested

Sponsor: AUG Therapeutics · Participants: 2 · Started: Apr 10, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05754450

Locations in the U.S.

MinnesotaMayo Clinic, Rochester

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.