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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT04143295
Eligibility Criteria:
Inclusion Criteria
* Genetic Confirmation: Male fetus or fetuses (including monozygotic twin pregnancies) must have a confirmed MCT8 gene mutation.
* Family History: A previously born child or children with a severe, typical phenotype and an MCT8 gene mutation identical to that of the fetus.
* Alternatively, the mother or a sister must have a relative with a known MCT8 defect.
* Parental Decision: Parental refusal to terminate the pregnancy despite the diagnosis of MCT8 deficiency.
* Compliance and Availability: Willingness of the parents to comply with all study procedures and ensure availability for the duration of the study.
Exclusion Criteria:
• Pregnancy-Related Factors: Dizygotic (non-identical) twin pregnancy (unless only one fetus is confirmed with the MCT8 mutation, and the unaffected fetus will not be treated).
Parental decision to terminate the pregnancy.
• Maternal Medical Conditions: Hyperthyroidism requiring treatment. Significant liver or kidney insufficiency. Congestive heart failure. Hyperemesis gravidarum unresponsive to treatment.
* Significant cardiac conditions, including:
* Atrial fibrillation or other arrhythmias.
* Unstable angina.
* Coronary heart disease.
* Medications:
Current use of sympathomimetic therapy. Anticoagulant therapy. Use of Cytochrome P450 2C9 (CYP2C9) inhibitors with a narrow therapeutic index.
• Other Factors: Major illness or recent major surgery within four weeks of baseline visit 1, unrelated to MCT8 deficiency.
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
18 Years
Study:
NCT04143295
Study Brief:
Protocol Section:
NCT04143295