RecruitingNCT04454216

GSD VI and GSD IX Natural History


Sponsor

Duke University

Enrollment

400 participants

Start Date

Sep 18, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Collection and review of clinical information related to Glycogen Storage Disease Type VI (GSD VI) OR Glycogen Storage Disease Type IX (GSD IX) generated during clinic visits.


Eligibility

Min Age: 0 YearsMax Age: 90 Years

Inclusion Criteria7

  • Diagnosis of GSD VI or GSD IX via:
  • Two variants in the PYGL, PHKA1, PHKA2, PHKG1, PHKG2, or PHKB gene (or one variant with evidence of disease). Note: for males, one variant in the PHKA1 or PHKA2 gene is sufficient for inclusion.
  • Deficient GP activity or PhK activity per enzymology
  • Histology as confirmed by clinician
  • Pregnant women with a diagnosis of GSD VI or GSD IX will be included
  • Able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative)
  • Able to provide consent for release of medical records

Exclusion Criteria1

  • Unable to provide informed consent for participation for one's self or by legally authorized representative/legal guardian/parent

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERNo intervention

This is an observational study that consists of data abstraction from patient medical records.


Locations(1)

Duke University

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04454216