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Evaluation of the efficacy and safety of empagliflozin in the treatment of neutropenia in patients with glycogenosis Ib. EMPAtia.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512840-52-00
Acronym
EMPAtia
Enrollment
20
Registered
2024-12-02
Start date
2022-03-03
Completion date
2025-04-03
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycogenosis type Ib is an ultra-rare disease, inherited in an autosomal recessive manner.

Brief summary

The primary endpoint will be an assessment of the safety and tolerability of empagliflozin, expressed as the type and frequency of adverse reactions throughout the study period. Safety data will be collected at all visits and will be related to possible adverse reactions to empagliflozin as described in the summary of product characteristics.

Detailed description

The secondary objective is to assess efficacy expressed as restoration of neutrophil numbers and function

Interventions

DRUGJardiance 10 mg film-coated tablets

Sponsors

Instytut Pomnik Centrum Zdrowia Dziecka
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be an assessment of the safety and tolerability of empagliflozin, expressed as the type and frequency of adverse reactions throughout the study period. Safety data will be collected at all visits and will be related to possible adverse reactions to empagliflozin as described in the summary of product characteristics.

Secondary

MeasureTime frame
The secondary objective is to assess efficacy expressed as restoration of neutrophil numbers and function

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026