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NCT02698579 · ClinicalTrials.gov registry record
Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product
A clinical trial of Cerebral Adrenoleukodystrophy (CALD) and Adrenoleukodystrophy (ALD), sponsored by Genetix Biotherapeutics.
- Active
- Registry status
- 64
- Enrollment target
- 13
- Study locations
NCT02698579: Active study of Cerebral Adrenoleukodystrophy (CALD) and Adrenoleukodystrophy (ALD), sponsored by Genetix Biotherapeutics.
NCT02698579 is a study of Cerebral Adrenoleukodystrophy (CALD) and Adrenoleukodystrophy (ALD) that is active but no longer recruiting, run by Genetix Biotherapeutics. The registered enrollment target is 64 participants, roughly in line with the 64-participant average among 3 other Cerebral Adrenoleukodystrophy (CALD) trials with a reported enrollment target. The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02698579, a study of Cerebral Adrenoleukodystrophy (CALD) and Adrenoleukodystrophy (ALD), is active but no longer recruiting, sponsored by Genetix Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- 64 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
The MFDs are loss of communication, cortical blindness, tube feeding, total incontinence, wheelchair dependence, complete loss of voluntary movement.
Conditions Studied
Interventions
- GENETIC No interventional drug product utilized in this follow-up study
Study Locations (13)
Other
- Instituto Neurogenia - Caba
- Women's and Children's Hospital - North Adelaide
- Hospital das Clínicas da Universidade de São Paulo - São Paulo
- Universitätsklinikum Leipzig AöR - Leipzig
- Ospedale Pediatrico Bambino Gesù - Rome
- Prinses Maxima Center - Utrecht
- Great Ormond Street Hospital - London
California
- Mattel Children's Hospital-UCLA - Los Angeles
- Lucile Packard Children's Hospital - Stanford - Palo Alto
Massachusetts
- Boston Children's Hospital/Massachusetts General Hospital - Boston
Minnesota
- University of Minnesota - Minneapolis
Cedex
- Hôpital Bicêtre - Le Kremlin-Bicêtre
England
- Royal Free London Hospital - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2016-01-22 |
| Est. Completion | 2038-08 |
What the registry record for NCT02698579 still lists
NCT02698579 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 64-participant average among 3 other Cerebral Adrenoleukodystrophy (CALD) trials with a reported enrollment target.
The record links to 3 conditions, with Cerebral Adrenoleukodystrophy (CALD) appearing as the primary indexed condition, and to 1 intervention - of which No interventional drug product utilized in this follow-up study is the first listed.
NCT02698579 lists 13 locations in 6 states (Other, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02698579 about?
NCT02698579 is a clinical study titled "Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product". 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 ye...
What is the current status of trial NCT02698579?
This trial is currently active not recruiting. The enrollment target is 64 participants. The study started on 2016-01-22. Estimated completion is 2038-08.
What conditions does trial NCT02698579 study?
This clinical trial studies the following conditions: Cerebral Adrenoleukodystrophy (CALD), Adrenoleukodystrophy (ALD), X-Linked Adrenoleukodystrophy (X-ALD).
What interventions are being tested in trial NCT02698579?
The interventions under investigation include: No interventional drug product utilized in this follow-up study (GENETIC).
Who is sponsoring clinical trial NCT02698579?
This trial is sponsored by Genetix Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02698579 being conducted?
This trial has 13 study locations across California, Massachusetts, Minnesota, Cedex, England. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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