An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II
NCT ID: NCT05754450
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2 participants
INTERVENTIONAL
2023-04-10
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AVTX-803
AVTX-803 at a dose specified by the investigator up to 5 times a day not to exceed 1700 mg/kg/day
AVTX-803
L-fucose crystalline powder
Interventions
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AVTX-803
L-fucose crystalline powder
Eligibility Criteria
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Inclusion Criteria
* Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
Exclusion Criteria
* 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
6 Months
75 Years
ALL
No
Sponsors
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AUG Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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David Deyle
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Eva Morava-Kozicz, MD PhD
Role: primary
Other Identifiers
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AVTX-803-LAD-302
Identifier Type: -
Identifier Source: org_study_id
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