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NCT02633943 · ClinicalTrials.gov registry record
Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy
A clinical trial of Transfusion-dependent Beta-Thalassemia, sponsored by Genetix Biotherapeutics.
- Active
- Registry status
- 66
- Enrollment target
- 15
- Study locations
NCT02633943: Active study of Transfusion-dependent Beta-Thalassemia, sponsored by Genetix Biotherapeutics.
NCT02633943 is a study of Transfusion-dependent Beta-Thalassemia that is active but no longer recruiting, run by Genetix Biotherapeutics. The registered enrollment target is 66 participants, below the 91-participant average among 3 other Transfusion-dependent Beta-Thalassemia trials with a reported enrollment target (27% lower). The trial reports 15 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633943, a study of Transfusion-dependent Beta-Thalassemia, is active but no longer recruiting, sponsored by Genetix Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- 66 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (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.
Conditions Studied
Interventions
- OTHER Safety and efficacy assessments
Study Locations (15)
Other
- - Sydney
- - Marseille
- - Paris
- - Hanover
- - Heidelberg
- - Thessaloniki
- - Rome
- - Bangkok
- - London
California
- - Oakland
Illinois
- - Chicago
Maryland
- - Bethesda
New York
- - New York
Pennsylvania
- - Philadelphia
South Carolina
- - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-01 |
| Est. Completion | 2035-11 |
What the registry record for NCT02633943 still lists
NCT02633943 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 91-participant average among 3 other Transfusion-dependent Beta-Thalassemia trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Transfusion-dependent Beta-Thalassemia appearing as the primary indexed condition, and to 1 intervention - of which Safety and efficacy assessments is the first listed.
NCT02633943 lists 15 locations in 7 states (Other, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT02633943 about?
NCT02633943 is a clinical study titled "Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy". This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (approximatel...
What is the current status of trial NCT02633943?
This trial is currently active not recruiting. The enrollment target is 66 participants. The study started on 2014-01. Estimated completion is 2035-11.
What conditions does trial NCT02633943 study?
This clinical trial studies the following conditions: Transfusion-dependent Beta-Thalassemia.
What interventions are being tested in trial NCT02633943?
The interventions under investigation include: Safety and efficacy assessments (OTHER).
Who is sponsoring clinical trial NCT02633943?
This trial is sponsored by Genetix Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02633943 being conducted?
This trial has 15 study locations across California, Illinois, Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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