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Active Not Recruiting
NCT02698579
Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product
Conditions: Cerebral Adrenoleukodystrophy (CALD), Adrenoleukodystrophy (ALD), X-Linked Adrenoleukodystrophy (X-ALD)
Sex: Male
Ages: N/A – 19 Years
Healthy volunteers: No
Enrollment: 64
Sponsor: Genetix Biotherapeutics Inc.
Location: Mattel Children's Hospital-UCLA Los Angeles California
Summary
This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product (eli-cel) in a parent clinical study (Study ALD-102 or Study ALD-104).
After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.
Eligibility Criteria
Inclusion Criteria:
* Provision of written informed consent for this study by the participant or participant's parent(s)/ legal guardian(s) and written informed assent by participant, if applicable
* Have received eli-cel in a parent clinical study
Exclusion Criteria:
* There are no exclusion criteria for this study
Source: ClinicalTrials.gov (NCT02698579). StuddyBuddy aggregates publicly available trial information.
