Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01745120 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants
A Phase 1 study, sponsored by Genetix Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01745120 is a Phase 1 study that has completed, run by Genetix Biotherapeutics. The registered enrollment target is 19 participants.
The verdict
NCT01745120, a Phase 1 study, has completed, sponsored by Genetix Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18 participants (including at least 3 adolescents between 12 and 17 years of age, inclusive) with β-thalassemia major. The study will evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product \[autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human βA-T87Q-globin gene\].
Interventions
- GENETIC LentiGlobin BB305 Drug Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-02-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01745120
The ClinicalTrials.gov registry entry for NCT01745120 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genetix Biotherapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LentiGlobin BB305 Drug Product is the first listed.
NCT01745120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01745120 about?
NCT01745120 is a clinical study titled "A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants". This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18 participants (including at least 3 adolescents between 12 and 17 years of age, inclusive) with β-thalassemia major. The study will evaluate the safety and efficacy of autologous hematopoietic stem cell transpl...
What is the current status of trial NCT01745120?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2013-08. Estimated completion is 2018-02-21.
What interventions are being tested in trial NCT01745120?
The interventions under investigation include: LentiGlobin BB305 Drug Product (GENETIC).
Who is sponsoring clinical trial NCT01745120?
This trial is sponsored by Genetix Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.