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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avalo Therapeutics, Inc.

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