Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety of Empagliflozin in GSD-Ib Patients
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Summary
Empagliflozin Treatment of GSD-1b patients
Official title: Efficacy and Safety of Empagliflozin in Patients With Glycogen Storage Disease Type Ib
Key Details
Gender
All
Age Range
1 Year - 50 Years
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2023-07-15
Completion Date
2024-12-31
Last Updated
2026-06-18
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin
Oral administration of Empagliflozin: The starting dose was 0.3 mg/kg/day in 2 divided doses for 3 months. If the subject had an absolute neutrophil count \> 1.0 × 10\^9/L and clinical improvement (decreased number of infections and/or decreased IBD activity within 3 months), the maintenance dose was maintained. If the subject had an absolute neutrophil count \< 1.0 × 10\^9/L but clinical improvement (decreased number of infections and/or decreased IBD activity within 3 months), the maintenance dose was maintained and reassessed 1 month later. If the subject had an absolute neutrophil count \< 1.0 × 10\^9/L and no clinical improvement (no change in number of infections and/or no change in IBD activity within 3 months), the dose was increased by 0.1 mg/kg/day and reassessed 3 months later. Assessments were then performed every 3 months with the same dose modification criteria as above.
Locations (1)
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China