Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/21/2019 |
| Start Date: | January 2016 |
| End Date: | March 2036 |
This is a multi-center, long-term safety and efficacy follow-up study for subjects with
cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in a parent
clinical study.
After completing a parent clinical study (approximately 2 years), eligible subjects 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.
cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in a parent
clinical study.
After completing a parent clinical study (approximately 2 years), eligible subjects 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.
Inclusion Criteria:
- Provision of written informed consent for this study by the subject or subject's
parent(s)/ legal guardian(s) and written informed assent by subject, if applicable.
- Have received Lenti-D Drug Product in a parent clinical study.
- Able to comply with study requirements.
Exclusion Criteria:
- There are no exclusion criteria for this Study.
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