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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04138251
Eligibility Criteria:
Inclusion Criteria:
* Glycogenosis type 1b confirmed by biochemical analyzes and / or genetic analysis. These patients with Glycogenosis must have had a liver transplant
* Alternatively, G6PC3 deficiency confirmed by genetic analysis
* Age 1 to 18 years old female or male
* Informed consent signed by the recipient and / or parents / assigns.
* Information and agreement of the referring medical team.
* A Negative Blood Pregnancy Test at the time of screening and a negative urinary pregnancy test at Day 1 of the protocol are required for female with child bearing potential.
* Sexually active patients should use an effective method of contraception throughout the duration of the study and up to 7 days after the last dose of Empaglifozine. (The combination of a hormonal method and a barrier method; Two barrier methods, the male condom being one of these two methods;Use intrauterine device or tubal ligation;-A total sex abstinence.)
Exclusion Criteria:
* Presence of advanced fibrosis (Metavir F4) or cirrhosis.
* Impossibility of long-term and / or non-compliance monitoring.
* Other medical problems which, in the opinion of the physicians in charge of the patient, would constitute a contraindication to the procedure.
* Sexually active patients who do not consent to use effective contraception during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT04138251
Study Brief:
Protocol Section:
NCT04138251