Safety and Efficacy of Empagliflozin in GSD1b Patients With Neutropenia (NCT04930627) | Clinical Trial Compass
UnknownPhase 2
Safety and Efficacy of Empagliflozin in GSD1b Patients With Neutropenia
Poland20 participantsStarted 2021-07
Plain-language summary
Treatment of neutropenia of Glycogenosis type 1b patients with empagliflozin
Who can participate
Age range4 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Minimum age 4 weeks old female Or Male
* GSD1b confirmed by genetic analysis with neutropenia and/or reduced respiratory burst
* Informed consent signed by the parents/assigns, and the recipient (\>13 years old)
Exclusion Criteria:
* Risk of non-compliance
* Chronic renal diseases (eGFR \< 60 ml/min/1,73 m2)
* Active urinary tract infection (temporal criterion, up to recovery)
* Participation in another clinical trial (minimum 6 months from the end of participation until the date of signing the Informed Consent Form)
* Participation in therapeutic experiment, in addition to the experimental treatment with empagliflozin (minimum 12 months from the end of participation until the date of signing the Informed Consent Form)
* Pregnancy, breastfeeding
* Allergy to Empagliflozin
* Lack of informed consent
What they're measuring
1
Empaglifozin safety and tolerability measured by occurrence of adverse reactions
Timeframe: 2 years
Trial details
NCT IDNCT04930627
SponsorChildren's Memorial Health Institute, Poland