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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04581733
Eligibility Criteria:
Inclusion Criteria:
* Subject must be aged birth to \<18 years of age on the day of consent.
* Diagnosis of TK2 deficiency based on confirmed disease-causing mutation(s) in the TK2 gene.
* Onset of TK2d at ≤12 years of age as defined as the age at which the first TK2d symptom occurred.
Exclusion Criteria:
* Documented clinically significant central nervous system involvement.
* ALT or AST \>3 x upper limit of normal and total bilirubin \> 2 x ULN or International Normalized Ratio (INR) \>1.5.
* EtCO2\>45 mmHg if not on ventilatory support
* Current or prior treatment with nucleos(t)ides for TK2d.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT04581733
Study Brief:
Protocol Section:
NCT04581733