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

Launched by AUG THERAPEUTICS · Mar 2, 2023

Keywords

ClinConnect Summary

This clinical trial, called an extension study, is looking at the long-term safety and effectiveness of a treatment called AVTX-803 for people with a rare condition known as Leukocyte Adhesion Deficiency Type II (LAD II). This condition affects how the body’s immune cells work and can lead to serious infections. The study is currently recruiting participants aged between 18 and 27393, and both men and women are welcome to join.

To be eligible for this study, participants must have already completed a previous study involving AVTX-803 and have a confirmed diagnosis of LAD II through specific tests. However, individuals with severe anemia, kidney problems, or known allergies to certain ingredients in the treatment cannot participate. If you join the study, you can expect to be monitored over time to see how well the treatment works and whether it is safe. This trial is an important step in understanding how AVTX-803 can help manage this challenging condition.

Gender

ALL

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