Safety and Efficacy of Empagliflozin in GSD1b Patients With Neutropenia
- Sponsor
- Children's Memorial Health Institute, Poland
- Study ID
- NCT04930627
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Glucose 6 Phosphatase Deficiency
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Weeks - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin — DRUGdosis depending on body weight: \<20 kg 5 mg 1x/day; 20-40 kg 2 x 5 mg; \>40 kg 2 x 10 mg
Study Details
Treatment of neutropenia of Glycogenosis type 1b patients with empagliflozin
Key Dates
- Start date
- Jul 31, 2021
- Status verified
- Jun 2021
- Primary completion
- Jun 30, 2024
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: oral administration of Empagliflozin
Primary Outcome Measure
Empaglifozin safety and tolerability measured by occurrence of adverse reactions [ Time Frame: 2 years ]