Actively Recruiting

Age: 2Years +
All Genders
NCT06636383

Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

Led by Ultragenyx Pharmaceutical Inc · Updated on 2026-04-23

140

Participants Needed

19

Research Sites

630 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration.

CONDITIONS

Official Title

Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient who had DTX401 (full or partial dose) administered in a parent clinical study (Group 1) or prescribed DTX401 (full or partial dose) administered in a post-marketing setting (Group 2)
  • Patient is willing and able to provide informed consent after the study has been explained
  • If a minor or adult with cognitive limitations, patient is willing and able to provide assent and have a legally authorized representative provide informed consent after the study has been explained
Not Eligible

You will not qualify if you...

  • Presence of any condition that would interfere with study participation, interpretation of results, or affect patient's safety in the opinion of the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

2

Children's Hospital Colorado

Denver, Colorado, United States, 80045

Actively Recruiting

3

University of Connecticut Health Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

4

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

5

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

6

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

7

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

8

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

9

Primary Children's Hospital

Salt Lake City, Utah, United States, 84108

Not Yet Recruiting

10

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, Brazil, 90035-903

Actively Recruiting

11

McGill University Health Center

Montreal, Quebec, Canada, H4A3J1

Actively Recruiting

12

Rigshospitalet

Copenhagen, Denmark, 2700

Actively Recruiting

13

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany, 20246

Actively Recruiting

14

University of Naples

Naples, Campania, Italy, 80131

Actively Recruiting

15

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genoa, Italy, 16147

Actively Recruiting

16

Osaka City General Hospital

Osaka, Japan, 534-0021

Actively Recruiting

17

Fujita Health University Hospital

Toyoake, Japan, 470-1192

Actively Recruiting

18

Groningen University

Groningen, Netherlands, 9700 RB

Actively Recruiting

19

Hospital Clínico Universitario de Santiago

Santiago, Spain, 15706

Actively Recruiting

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Research Team

P

Patients Contact: Trial Recruitment

CONTACT

H

HCPs Contact: Medical Information

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program | DecenTrialz