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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT06713135
Eligibility Criteria:
Inclusion Criteria:
* Subject and/or subject's parent(s) or legal guardian has provided written informed consent
* Subject has previously completed either the VBP15-LTE or VBP15-004 study, and transitioned through the Compassionate Use Program, Named Patient Program or Expanded Acess Protocol
* Subject is on vamorolone on day of enrolment
* Subject and parent / legal guardian are willing and able to comply with the protocol schedule, assessments and requirements
Exclusion Criteria:
* Any medical condition, which in the opinion of the Investigator, would affect study participation, performance or interpretation of study assessments
* Vamorolone treatment discontinued for ≥ 6 months within the year prior to enrolment for a non-safety reason, or vamorolone treatment previously discontinued at any time for a safety reason
* Severe hepatic impairment
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT06713135
Study Brief:
Protocol Section:
NCT06713135