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Cancer Immunotherapy

AVTX-803 for Leukocyte Adhesion Deficiency

Phase 3
Recruiting
Led By David Deyle
Research Sponsored by AUG Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to find out if a drug is safe and effective for people with SLC35C1-CDG over a long period.

Who is the study for?
This trial is for individuals who have completed the AVTX-803-LAD-301 protocol and are confirmed to have Leukocyte Adhesion Deficiency Type II. They must not have severe anemia, impaired kidney function, or intolerance to fucose or any ingredients in AVTX-803.
What is being tested?
The study aims to evaluate the long-term safety and effectiveness of a treatment called AVTX-803 in patients with LAD II, a rare genetic disorder affecting white blood cells' ability to adhere properly.
What are the potential side effects?
While specific side effects of AVTX-803 aren't listed here, common concerns may include allergic reactions to its components or potential issues related to long-term use which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline in the composite Nijmegen Pediatric Congenital Disorders of Glycosylation (CDG) Rating Scale (NPCRS)
Change from Baseline in the individual parameters of the Nijmegen Pediatric Congenital Disorders of Glycosylation (CDG) Rating Scale (NPCRS)
Clinician Global Impression of Severity (CGI-S)
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AVTX-803Experimental Treatment1 Intervention
AVTX-803 at a dose specified by the investigator up to 5 times a day not to exceed 1700 mg/kg/day

Find a Location

Who is running the clinical trial?

AUG TherapeuticsLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Leukocyte Adhesion Deficiency
4 Patients Enrolled for Leukocyte Adhesion Deficiency
Avalo Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
2,104 Total Patients Enrolled
1 Trials studying Leukocyte Adhesion Deficiency
4 Patients Enrolled for Leukocyte Adhesion Deficiency
David DeylePrincipal InvestigatorMayo Clinic
Garry Neil, MDStudy DirectorAvalo Therapeutics, Inc.
2 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Leukocyte Adhesion Deficiency
4 Patients Enrolled for Leukocyte Adhesion Deficiency

Media Library

AVTX-803 (Cancer Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05754450 — Phase 3
Leukocyte Adhesion Deficiency Research Study Groups: AVTX-803
Leukocyte Adhesion Deficiency Clinical Trial 2023: AVTX-803 Highlights & Side Effects. Trial Name: NCT05754450 — Phase 3
AVTX-803 (Cancer Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05754450 — Phase 3
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