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AVTX-803 for Leukocyte Adhesion Deficiency
Study Summary
This trial is testing a new drug to see if it works better than current treatment for a rare disease called Leukocyte Adhesion Deficiency, Type II.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am a woman who could become pregnant.I agree to use two forms of birth control during and 30 days after the study.I am between 6 months and 75 years old.I often get infections that don't get better with usual treatments.My kidney function is reduced, with an eGFR below 90 mL/min.My red blood cells lack fucosylation and have anti-H antigen.My hemoglobin level is below 8.0 g/dL.My body did not respond to fucose treatment despite proper dosing.You have a known or suspected allergy or sensitivity to fucose or any ingredients in the experimental product.I have been diagnosed with LAD II through genetic and biochemical tests.I have a documented deficiency in Lewis antigen.
- Group 1: Withdrawal
- Group 2: AVTX-803
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
If a patient is a senior citizen, do they still meet the requirements for this clinical trial?
"This clinical trial is recruiting participants that are over 6 months old and under 75 years of age."
Are there any patients presently taking part in this clinical trial?
"The latest information on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was first posted on July 28th, 2020 and the listing was most recently updated on August 4th, 2020."
How many individuals are taking part in this clinical trial?
"Indeed, the clinicaltrials.gov website reveals that this experiment is still searching for subjects. The trial was initially posted on 7/28/2022 and underwent its most recent edit on 8/4/2022. So far, 1 site has recruited 4 individuals."
Has AVTX-803 (L-Fucose) received regulatory approval from the FDA?
"Based on our team's assessment, AVTX-803 (L-Fucose) has been deemed safe for use because it is a Phase 3 trial medication. This suggests that not only does the drug have some efficacy, but that there is also multiple rounds of data to support its safety."
For which patients is this research applicable?
"This clinical trial is seeking 4 individuals that suffer from leukocyte adhesion deficiency and are between the ages of 6 months to 75 years old. The most notable requirements for applicants are as follows: a documented history of Lewis antigen deficiency, biochemically and genetically proven LAD II (SLC35C1-CDG), a history of recurrent infections or infections unresponsive to standard care treatment, written informed consent from the subject or parent/guardian, willing to comply with the protocol, non-lactating, negative pregnancy test result at screening, and using an acceptable double-barrier method of contraception throughout the study period and"
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