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Cancer Immunotherapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment emergent adverse events reported during the study attributable to AVTX-803.

Secondary outcome measures

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)

+2 more

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

Do I qualify?Apply below to find out

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

11 Previous Clinical Trials

1,924 Total Patients Enrolled

1 Trials studying Leukocyte Adhesion Deficiency

4 Patients Enrolled for Leukocyte Adhesion Deficiency

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

Frequently Asked Questions

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

What possible risks have been linked to AVTX-803 therapy?

"We at Power rate AVTX-803 with a score of 3, as the Phase 3 trial for this drug has yielded encouraging evidence for its efficacy and several rounds of data indicating that it is safe."

Answered by AI

Who is the target demographic for this clinical investigation?

"The requirements for this clinical trial are leukocyte adhesion deficiency, an age between 6 Months and 75 years old, and the study is only recruiting a maximum of 2 people."

Answered by AI

Are enrollment applications still being accepted for this research endeavor?

"Per clinicaltrials.gov, patient recruitment for this trial has been temporarily suspended since its posting on February 21st 2023 and latest update of March 2nd 2023. Although the study is inactive presently, there are 27 other medical studies that remain open to participants at present."

Answered by AI

Are participants for this research limited to people under 35 years of age?

"This research protocol only allows those aged 6 months to 75 years old to participate. For minors and elderly people, there are 5 studies for the former cohort and 13 trials for the latter group."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05754450.