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AVTX-801 D-galactose Supplementation in SLC35A2-CDG

NCT05402384 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-29

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of AVTX-801 in subjects with SLC35A2-CDG

Conditions

  • SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Interventions

DRUG

AVTX-801

Medical grade D-galactose dosage:2.0 g/kg/day

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Rare Diseases Clinical Research Network

    collaborator NETWORK

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Eva Morava-Kozicz

    lead OTHER

Principal Investigators

  • Eva Morava-Kozicz, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402384 on ClinicalTrials.gov