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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT03652259
Eligibility Criteria:
INCLUSION CRITERIA
* Males or females of any ethnic group
* β-SG deoxyribonucleic acid (DNA) gene mutations at both alleles
* Weakness demonstrated based on history of difficulty in running, jumping and climbing stairs
* A 100 meter walk/run (MWR) test result: ≥40 % of predicted for age-, height-, gender-, and weight-matched healthy controls at the screening visit
EXCLUSION CRITERIA
* Active viral infection based on clinical observations
* Cardiac magnetic resonance imaging (MRI) determined left ventricular ejection fraction (LVEF) \<40%
* Serological evidence of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
* Diagnosis of (or ongoing treatment for) an autoimmune disease
* Abnormal laboratory values considered clinically significant
* Concomitant illness or requirement for chronic drug treatment that, in the opinion of the Principal Investigator, creates unnecessary risks for gene transfer.
Other inclusion/exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
15 Years
Study:
NCT03652259
Study Brief:
Protocol Section:
NCT03652259