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NCT02140554 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety and Efficacy of Lovo-cel in Severe Sickle Cell Disease
A Phase 1 study, sponsored by Genetix Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02140554: Completed Phase 1 study, sponsored by Genetix Biotherapeutics.
NCT02140554 is a Phase 1 study that has completed, run by Genetix Biotherapeutics. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02140554, a Phase 1 study, has completed, sponsored by Genetix Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a non-randomized, open label, multi-site, single dose, Phase 1/2 study in approximately 50 adults and adolescents with severe SCD. The study will evaluate hematopoietic stem cell and progenitor stem cell (collectively referred to as hematopoietic stem and progenitor cells or HSPCs) transplantation using lovo-cel.
Primary Outcome
VOE-CR was defined as complete resolution of adjudicated VOEs between 6 months and 18 months post lovo-cel infusion. All reported VOEs were also adjudicated by an independent Event Adjudication Committee for purposes of endpoint analysis. VOEs were determined by adjudication committee after referring to protocol VOE. The committee was responsible for VOE assessment and determining whether an event met criteria for a VOE for all reported events.
Interventions
- GENETIC lovo-cel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-02-02 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 1 |
What the finished NCT02140554 record still lists
NCT02140554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which lovo-cel is the first listed.
NCT02140554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02140554 about?
NCT02140554 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Lovo-cel in Severe Sickle Cell Disease". This is a non-randomized, open label, multi-site, single dose, Phase 1/2 study in approximately 50 adults and adolescents with severe SCD. The study will evaluate hematopoietic stem cell and progenitor stem cell (collectively referred to as hematopoietic stem and progenitor cells or HSPCs) transplan...
What is the current status of trial NCT02140554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2015-02-02. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT02140554?
The interventions under investigation include: lovo-cel (GENETIC).
Who is sponsoring clinical trial NCT02140554?
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 NCT02140554's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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