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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
AUG Therapeutics
Study ID
NCT05754450
Phase
PHASE3
Status
Recruiting

Conditions

  • Leukocyte Adhesion Deficiency

Eligibility Criteria

Sex
ALL
Age
6 Months - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AVTX-803 — DRUG
    L-fucose crystalline powder

Study Details

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).

Key Dates

Start date
Apr 10, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AVTX-803
    AVTX-803 at a dose specified by the investigator up to 5 times a day not to exceed 1700 mg/kg/day

Primary Outcome Measure

Incidence of treatment emergent adverse events reported during the study attributable to AVTX-803. [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Queenie Tan, MD PhD

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