Safety, Efficacy Evaluation of Empagliflozin Administration for Neutropenia in Glycogenosis Type 1b and G6PC3 Deficiency

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT04138251
Phase
PHASE2
Status
Unknown

Conditions

  • Glucose 6 Phosphatase Deficiency
  • Glycogen Storage Disease Type I

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Treatment of neutropenia of G6PC3 and Glycogenosis type 1b patients with empagliflozin

Key Dates

Start date
Jun 20, 2019
Status verified
Oct 2019
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Oral empaglifozin 5 mg 1x/day, increase up to 10 mg 1x/day if no 25% decrease of blood1,5-anhydroglucitol level

Primary Outcome Measure

Empaglifozin safety (blood test-glycemia): measured by absence of hypoglycaemia due to gliflozin treatment [ Time Frame: from start of treatment to 2 months post treatment ]

Central Contacts

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