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.
Investigators
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
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