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AVTX-803 for Leukocyte Adhesion Deficiency

Phase 3
Recruiting
Research Sponsored by AUG Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential (WOCBP) meeting the criteria below:
Male subjects must agree to use an acceptable double-barrier method of contraception with their partner as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at day 56, change from baseline at day 112
Awards & highlights

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.

Who is the study for?
This trial is for people aged 6 months to 75 years with Leukocyte Adhesion Deficiency Type II. Participants must have a history of recurrent or poorly responding infections and agree to use double-barrier contraception. It's not for those intolerant to fucose, with kidney issues (eGFR <90 mL/min), severe anemia, or who are pregnant.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of AVTX-803 (L-Fucose) in patients with LAD II compared to those who stop treatment. The goal is to see if this intervention can help manage symptoms associated with the condition.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions related to intolerance or hypersensitivity to fucose or other ingredients in AVTX-803.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who could become pregnant.
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I agree to use two forms of birth control during and 30 days after the study.
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I am between 6 months and 75 years old.
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I often get infections that don't get better with usual treatments.
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I have been diagnosed with LAD II through genetic and biochemical tests.
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I have a documented deficiency in Lewis antigen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at day 56, change from baseline at day 112
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at day 56, change from baseline at day 112 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of AVTX-803 on the percent of leukocytes expressing Sialyl-Lewis X antigen

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AVTX-803Experimental Treatment1 Intervention
Approximately 4 subjects will receive AVTX-803 at a dose specified by the investigator up to 5 times a day not to exceed 1700 mg/kg/day for 8 weeks.
Group II: WithdrawalActive Control1 Intervention
Subject will be in withdrawal for 8 weeks.

Find a Location

Who is running the clinical trial?

AUG TherapeuticsLead Sponsor
1 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Leukocyte Adhesion Deficiency
2 Patients Enrolled for Leukocyte Adhesion Deficiency
Avalo Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,922 Total Patients Enrolled
1 Trials studying Leukocyte Adhesion Deficiency
2 Patients Enrolled for Leukocyte Adhesion Deficiency
Garry Neil, MDStudy DirectorAvalo Therapeutics, Inc.
2 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Leukocyte Adhesion Deficiency
2 Patients Enrolled for Leukocyte Adhesion Deficiency

Media Library

AVTX-803 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05462587 — Phase 3
Leukocyte Adhesion Deficiency Research Study Groups: Withdrawal, AVTX-803
Leukocyte Adhesion Deficiency Clinical Trial 2023: AVTX-803 Highlights & Side Effects. Trial Name: NCT05462587 — Phase 3
AVTX-803 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462587 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~1 spots leftby Sep 2024