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NCT02462252 · ClinicalTrials.gov registry record · Phase 2
Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome
A Phase 2 study, sponsored by BioLineRx.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT02462252: Completed Phase 2 study, sponsored by BioLineRx.
NCT02462252 is a Phase 2 study that has completed, run by BioLineRx. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02462252, a Phase 2 study, has completed, sponsored by BioLineRx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
An open label single arm study to assess efficacy and safety of BL-8040 on top of standard immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and AA over the course of a six month (180 day) treatment period.
Primary Outcome
95% confidence interval (CI) will be calculated for subjects who achieve Complete response (CR), Partial response (PR), for all AA and MDS subjects, and hematological improvement (HI) for MDS subjects only. Measurement in percentages (%)
Interventions
- DRUG Methylprednisolone
- DRUG Cyclosporine
- DRUG BL-8040
- DRUG horse anti-thymocyte globulin (hATG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-11 |
| Phase | Phase 2 |
What the finished NCT02462252 record still lists
NCT02462252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Methylprednisolone is the first listed.
NCT02462252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02462252 about?
NCT02462252 is a clinical study titled "Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome". An open label single arm study to assess efficacy and safety of BL-8040 on top of standard immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and AA over the course of a six month (180 day) treatment period.
What is the current status of trial NCT02462252?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2015-10. Estimated completion is 2020-11.
What interventions are being tested in trial NCT02462252?
The interventions under investigation include: Methylprednisolone (DRUG), Cyclosporine (DRUG), BL-8040 (DRUG), horse anti-thymocyte globulin (hATG) (DRUG).
Who is sponsoring clinical trial NCT02462252?
This trial is sponsored by BioLineRx, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02462252's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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