RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2023-04-10
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05754450

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.

Ages Eligible for Study:6 Months to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject must have completed protocol AVTX-803-LAD-301
  2. * Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
  1. * Subject has severe anemia defined as hemoglobin \<8.0 g/dL (\<4.9 mmol/L)
  2. * Subject has impaired renal function as defined by an eGFR \<90 mL/min
  3. * Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product
  4. * In the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing

Contacts and Locations

Study Contact

Jennifer Lin
CONTACT
3052833827
huiyil@Augtx.com

Principal Investigator

David Deyle
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: AUG Therapeutics

  • David Deyle, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-10
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-04-10
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Leukocyte Adhesion Deficiency