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NCT01877837 · ClinicalTrials.gov registry record · Phase 3
Stem Cell Transplantation for Sickle Cell Anemia
A Phase 3 study, sponsored by Hackensack Meridian Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01877837: Completed Phase 3 study, sponsored by Hackensack Meridian Health.
NCT01877837 is a Phase 3 study that has completed, run by Hackensack Meridian Health. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01877837, a Phase 3 study, has completed, sponsored by Hackensack Meridian Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This protocol will be investigating the use of stem cell transplantation, in related donors, to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point mutation that results in the substitution of valine for glutamic acid at the sixth position in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to vaso-occlusion, which causes irreversible damage in almost all systems in the body, including the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.
Primary Outcome
Primary endpoint: In each group, the Number of participants with Graft Failure at the 2 years endpoint will be estimated using the Kaplan Meier product limit estimator.
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Alemtuzumab
- PROCEDURE Stem Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-06 |
| Est. Completion | 2021-09 |
| Phase | Phase 3 |
What the finished NCT01877837 record still lists
NCT01877837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT01877837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01877837 about?
NCT01877837 is a clinical study titled "Stem Cell Transplantation for Sickle Cell Anemia". This protocol will be investigating the use of stem cell transplantation, in related donors, to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point mutation that results in the substitution of valine for glutamic acid at the sixth position in the B-chain of hemogl...
What is the current status of trial NCT01877837?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2021-09.
What interventions are being tested in trial NCT01877837?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Alemtuzumab (DRUG), Stem Cells (PROCEDURE).
Who is sponsoring clinical trial NCT01877837?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01877837's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 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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