Skip to main content
Clinical Trials/NL-OMON51818
NL-OMON51818
Recruiting
Not Applicable

Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Patients 1 Year of Age and Over with GSD III. - UX053-CL002

ltragenyx pharmaceutical Inc.0 sites2 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glycogen Storage Disease III
Sponsor
ltragenyx pharmaceutical Inc.
Enrollment
2
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
ltragenyx pharmaceutical Inc.

Eligibility Criteria

Inclusion Criteria

  • 1\. Male or female 1 year of age or older at time of informed consent/assent
  • 2\. Diagnosis of GSD III, confirmed by AGL sequencing or GDE enzymatic testing
  • 3\. Provide informed consent after the nature of the study has been explained,
  • and prior to
  • any research\-related procedures. If a minor or an adult with cognitive
  • limitations, willing
  • and able (if possible) to provide assent and have a legally authorized
  • representative
  • provide informed consent after the nature of the study has been explained, and
  • any research\-related procedures

Exclusion Criteria

  • 1\. Subject is unwilling to remain blinded to CGM data, or the Investigator
  • determines that blinding would compromise subject safety
  • 2\. Presence or history of any condition that, in the view of the Investigator,
  • would interfere with participation or pose undue risk
  • 3\. Use of any IP or investigational medical device within 30 days or 5\.5
  • half\-lives, whichever is longer, prior to screening, or during the study

Outcomes

Primary Outcomes

Not specified

Similar Trials