Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Participants With Glycogen Storage Disease Type III

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-20

Study Completion Date

2023-03-02

Brief Summary

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The primary objective of this study is to evaluate the incidence of hypoglycemia in adult and pediatric participants with glycogen storage disease type III (GSD III).

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Detailed Description

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Conditions

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Glycogen Storage Disease Type III

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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No Intervention

No investigational product (IP) will be administered in this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of GSD III, confirmed by amylo-alpha-1,6-glucosidase 4-alpha-glucanotransferase (AGL) sequencing or glycogen debranching enzyme (GDE) enzymatic testing

Exclusion Criteria

* Participant is unwilling to remain blinded to continuous glucose monitor (CGM) data for the first 13 weeks of the study, or the Investigator determines that blinding would compromise subject safety
* Presence or history of any condition that, in the view of the Investigator, would interfere with participation or pose undue risk
* 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

Note: Other criteria may apply per protocol

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No