Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT04986735
Eligibility Criteria:
Inclusion Criteria:
\- Subject (aged 6 months to 18 years) is enzymatically/genetically confirmed to have GSD 1b and has been on regular GCSF treatment for \>= 1 month
Exclusion Criteria:
* Subject fails to provide relevant background medical information, or comply with all requirements of the clinical trial, or sign the informed consent
* Subject has any co-morbidity or condition that could increase the risk of empagliflozin treatment (e.g. renal failure with eGFR \<30 mL/min/1.73m2 or requiring dialysis, diabetes requiring insulin \&/or oral hypoglycemic agents, dyslipidemia requiring pharmacological intervention)
* Subject is pregnant, or a sexually active female who does not consent to use effective contraception during the study
* History of liver transplantation is NOT an exclusion criterium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT04986735
Study Brief:
Protocol Section:
NCT04986735