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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT04021732
Eligibility Criteria:
Inclusion Criteria for subjects:
* Informed consent as documented by signature
* Confirmed biallelic mutation of cystathionine beta-synthase deficiency gene (homozygous or compound heterozygous) in an accredited Laboratory
* Continuation of their regular treatment under same dose (e.g. vitamin B6, B9 and B12, betaine) as prior to the study inclusion
Inclusion Criteria for controls:
\- Healthy
Exclusion Criteria:
* Any clinically instable concomitant disease
* Individuals with acute cardiac events, syncope, rhythm disturbances or unstable hypertension in the past 6 months
* Individuals with vitamins B9 or B12 deficiencies
* Homocysteine \> 100 µmol/l (for subjects)
* Homocysteine \> 20 µmol/l (for controls)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04021732
Study Brief:
Protocol Section:
NCT04021732