An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects With Leukocyte Adhesion Deficiency Type II
Recruiting
Phase 3
Interventional Study
Leukocyte Adhesion Deficiency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2 (estimated)
- Sponsor
- AUG Therapeutics · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject must have completed protocol AVTX-803-LAD-301
* Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)
Exclusion Criteria:
* Subject has severe anemia defined as hemoglobin \<8.0 g/dL (\<4.9 mmol/L)
* Subject has impaired renal function as defined by a…
Contacts