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

Description

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).

Conditions

Leukocyte Adhesion Deficiency

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Study Overview

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Study Details

Study overview

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).

A Phase 3, Open-Label, Extension Study to Assess the Long-term Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)

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

Condition
Leukocyte Adhesion Deficiency
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subject must have completed protocol AVTX-803-LAD-301
  • * Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
  • * 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

Ages Eligible for Study

6 Months to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AUG Therapeutics,

David Deyle, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2024-12-31