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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 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.

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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.

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

FieldValue
Enrollment Target 64 participants
Start Date 2016-01-22
Est. Completion 2038-08

Sponsor

Genetix Biotherapeutics

12 total trials

What the Registry Record Tells You About NCT02698579

The ClinicalTrials.gov registry entry for NCT02698579 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 64-participant average among 3 other Cerebral Adrenoleukodystrophy (CALD) trials with a reported enrollment target. The listed sponsor is Genetix Biotherapeutics, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 6 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.