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NCT03207009 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia
A Phase 3 study, sponsored by Genetix Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT03207009 is a Phase 3 study that has completed, run by Genetix Biotherapeutics. The registered enrollment target is 19 participants.
The verdict
NCT03207009, a Phase 3 study, has completed, sponsored by Genetix Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0/β0, β0/IVS-I-110, or IVS-I-110/IVS-I-110 genotype. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product.
Interventions
- GENETIC LentiGlobin BB305 Drug Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03207009
The ClinicalTrials.gov registry entry for NCT03207009 describes a study currently listed as completed, categorized as Phase 3. 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.
NCT03207009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03207009 about?
NCT03207009 is a clinical study titled "A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Participants With Transfusion-Dependent β-Thalassemia". This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0/β0, β0/IVS-I-110, or IVS-I-110/IVS-I-110 genotype. The study will evaluate the efficacy and safety o...
What is the current status of trial NCT03207009?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2017-06-08. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT03207009?
The interventions under investigation include: LentiGlobin BB305 Drug Product (GENETIC).
Who is sponsoring clinical trial NCT03207009?
This trial is sponsored by Genetix Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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