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Clinical Trials in the USA / NCT05754450
Recruiting Phase 3

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

NCT05754450 · tracked via the Priya Life Science USA tracker
Sponsor
AUG Therapeutics
Phase
Phase 3
Started
2023-04-10
Last updated
2026-05-01

Condition(s) studied

Leukocyte Adhesion Deficiency

Investigational drug(s) / intervention(s)

AVTX-803 →

AVTX-803: L-fucose crystalline powder

Study 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

Sex
ALL
Min age
6 Months
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Mayo Clinic Rochester Minnesota Recruiting

More AUG Therapeutics trials in the USA

A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type II Recruiting

Other trials for the same condition

A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type II Recruiting
Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05754450 on ClinicalTrials.gov ↗ ← All trials in the USA