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WITHDRAWN
NCT05960617
PHASE2

Efficacy and Safety of Empagliflozin in GSD-Ib Patients

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Interventions

DRUG

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