Actively Recruiting

Phase 3
Age: 6Months - 75Years
All Genders
NCT05754450

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

Led by AUG Therapeutics · Updated on 2026-05-01

2

Participants Needed

1

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Months - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject must have completed protocol AVTX-803-LAD-301
  • Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

J

Jennifer Lin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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