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NCT02906202 · 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, Who do Not Have a β0/β0 Genotype
A Phase 3 study, sponsored by Genetix Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT02906202: Completed Phase 3 study, sponsored by Genetix Biotherapeutics.
NCT02906202 is a Phase 3 study that has completed, run by Genetix Biotherapeutics. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02906202, a Phase 3 study, has completed, sponsored by Genetix Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a single-arm, multi-site, single-dose, Phase 3 study in 23 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), also known as β-thalassemia major, who do not have a β0 mutation at both alleles of the hemoglobin β (HBB) gene. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product.
Primary Outcome
TI was defined as a weighted average hemoglobin (Hb) \>= 9 grams per deciliter (g/dL) without any packed red blood cell (pRBC) transfusions for a continuous period of \>= 12 months at any time during the study after drug product infusion.
Interventions
- GENETIC LentiGlobin BB305 Drug Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-08-08 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 3 |
What the finished NCT02906202 record still lists
NCT02906202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which LentiGlobin BB305 Drug Product is the first listed.
NCT02906202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02906202 about?
NCT02906202 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, Who do Not Have a β0/β0 Genotype". This is a single-arm, multi-site, single-dose, Phase 3 study in 23 participants less than or equal to (\<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), also known as β-thalassemia major, who do not have a β0 mutation at both alleles of the hemoglobin β (HBB) gene. The study will ...
What is the current status of trial NCT02906202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2016-08-08. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT02906202?
The interventions under investigation include: LentiGlobin BB305 Drug Product (GENETIC).
Who is sponsoring clinical trial NCT02906202?
This trial is sponsored by Genetix Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02906202's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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