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Evaluation of the efficacy and safety of empagliflozin in the treatment of neutropenia in patients with glycogenosis Ib. EMPAtia.
EU CTIS ID: 2024-512840-52-00
What this study is testing
The primary objective of the study is to evaluate the safety and tolerability of neutropenia treatment with empagliflozin in patients with GSD Ib
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria for the study Patients who meet all of the following criteria will be included in the study: - males and females - age of 4 weeks or older - biochemically and/or molecularly diagnosed Ib glycogenosis with neutropenia and/or abnormal NADPH oxidase activity in neutrophils - the expression of voluntary informed consent by the legal representative for children < 13 years of age, the legal representative and the patient for children >=13 years of age, and the patient himself for adult patients.
You likely can't join if
- Exclusion criteria for the study The following criteria exclude a patient from eligibility for the study: - risk of non-cooperation, including the risk of non-adherence to follow-up and non-adherence to dietary recommendations; - chronic kidney disease with eGFR < 60 ml/min/1.73 m2 - urinary tract infection (time criterion at the time of inclusion in the study, pending completion of treatment for UTI), - participation in another clinical trial (withdrawal period: 6 months from the end of participation until the date of signing the Informed Consent Form), - participation in a therapeutic experiment, other than experimental treatment with empagliflozin (grace period: 24 months from the end of participation until the date of signing the Informed Consent Form) - pregnancy, breastfeeding - allergy to the administered drugs - lack of consent to participate in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.