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NCT05754450
An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II
Conditions: Leukocyte Adhesion Deficiency
Sex: All
Ages: 6 Months – 75 Years
Phase: PHASE3
Enrollment: 2
Sponsor: Avalo Therapeutics, Inc.
Location: United States
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 Criteria
Inclusion Criteria:Subject must have completed protocol AVTX-803-LAD-301Subject 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/minSubject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational productIn the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing
Source: ClinicalTrials.gov (NCT05754450). StuddyBuddy aggregates publicly available trial information.