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Glycogen Storage Disease Type IA clinical trials

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NCT ID: NCT05139316 Active, not recruiting - Clinical trials for Glycogen Storage Disease Type IA

A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa)

Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy to maintain euglycemia and to maintain or improve the quality of glucose control.

NCT ID: NCT04909346 Terminated - Wilson Disease Clinical Trials

Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease

Start date: June 23, 2021
Phase:
Study type: Observational

The objective of this observational study is to evaluate the seroprevalence of anti-AAV antibodies in subjects with Ornithine Transcarbamylase (OTC) deficiency, Glycogen Storage Disease Type Ia (GSDIa), and Wilson Disease

NCT ID: NCT04708015 Completed - Clinical trials for Glycogen Storage Disease Type IA

Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa

Start date: November 5, 2020
Phase:
Study type: Observational

The primary objective of this study is to assess the percentage of time patients were in normal glucose control.

NCT ID: NCT04311307 Completed - Clinical trials for Glycogen Storage Disease Type IA

Endogenous Glucose Production in Patients With Glycogen Storage Disease Type Ia

ENGLUPRO GSDIa
Start date: January 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Glycogen storage disease type Ia (GSDIa) subjects retain a limited capacity for endogenous glucose production (EGP). To date, the origin of residual EGP in GSDIa patients is unknown. Either increased glycogen debranching or lysosomal glycogen breakdown can account for residual EGP in GSDIa. Innovative treatments for GSDIa (e.g. AAV8-mediated gene therapy and mRNA therapy) are being developed.Therefore, longitudinal minimally-invasive monitoring of outcomes after therapeutic interventions in GSD Ia subjects becomes warranted. The primary objective is to test the feasibility of EGP quantification in adult GSDIa subjects by stable isotopes after a single oral [6,6-2H2]glucose dose. Secondary objectives are to compare EGP assessed by a single oral [6,6-2H2]glucose dose (a) in GSDIa patients versus matched healthy participants, (b) among GSDIa patients, (c) in the pre-prandial state versus the fed state, (d) in the controlled hospital setting versus the home setting. Data collected from the continuous glucose monitoring data will also be compared

NCT ID: NCT03970278 Active, not recruiting - Clinical trials for Glycogen Storage Disease Type IA

Study of Long-Term Safety and Efficacy on Gene Therapy in Glycogen Storage Disease Type Ia

Start date: July 15, 2019
Phase:
Study type: Observational

The primary objective of this study is to determine the long-term safety of DTX401 following a single intravenous (IV) dose in adults with GSDIa.

NCT ID: NCT02054832 Completed - Clinical trials for Glycogen Storage Disease Type IA

Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch

Start date: November 2013
Phase: N/A
Study type: Observational

The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by adults and children with GSD and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if there is a change in quality of life perceived by adults and children and their parents with Glycosade.

NCT ID: NCT01854242 Completed - Clinical trials for Inflammatory Bowel Disease

Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

Start date: November 2013
Phase:
Study type: Observational

The purpose of this research study is to understand the relationship between inflammatory bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been established to have an association with IBD with clinical and histologic features that mirror those of Crohn disease. Development of the disease seems to be related to the defect of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in patients with GSD type Ia versus the general population.