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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT07055269
Eligibility Criteria:
Inclusion criteria for AACD patients are:
* Subjects with citrin deficiency, confirmed by genetic analysis to carry pathogenic variant(s) in the SLC25A13 gene
* Age from 18 years to 65 years inclusive
* Male or female
* Written informed consent has been given
* Understands and is willing, able and likely to comply with study procedures and restrictions
Inclusion criteria for healthy subjects are:
* Age from 18 years to 65 years inclusive, and not more than five years younger or older than the specified paired participant from the AACD group
* Same sex as the specified paired participant from the AACD group
* Same ethnicity the specified paired participant from the AACD group
* Written informed consent has been given
* Understands and is willing, able and likely to comply with study procedures and restrictions
Exclusion criteria for AACD patients are:
* acute and chronic disease requiring treatment of any kind, other than his/her AACD
* females who are pregnant or lactating or attempting to become pregnant
* use of any medication which, in the opinion of the investigator, is likely to interfere with liver function
Exclusion criteria for healthy subjects are:
* carry any pathogenic variant in the SLC25A13 gene
* current or recurrent disease that could affect the metabolic function of the liver
* acute and chronic disease requiring treatment of any kind
* females who are pregnant or lactating or attempting to become pregnant
* use of any medication which, in the opinion of the investigator, is likely to interfere with liver function
* weight loss ≥10% within 3 months before study screening
* daily alcohol consumption of more than 2 standard-sized beer for men and more than 1 standard-sized beer for women, or the equivalent
* BMI \> 30 kg/m2
* currently smoking \>1 cigarette daily
* liver transplant recipients
* type 1 and 2 diabetes
* currently on a ketogenic diet
* currently taking medium chain triglyceride (MCT) supplements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07055269
Study Brief:
Protocol Section:
NCT07055269