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NCT01891994 · ClinicalTrials.gov registry record · Phase 2
Extended Dosing With Eltrombopag for Severe Aplastic Anemia
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01891994: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01891994 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01891994, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: \- Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help improve blood counts in these patients. However, researchers do not know how long the drug can and should be taken for this type of anemia. Objectives: \- To look at whether 6 months of treatment with eltrombopag can improve patient s blood counts. Eligibility: \- Individuals at least 2 years of age who are taking eltrombopag for severe aplastic anemia. Design: * Participants will take eltrombopag by mouth once a day for 6 months. * Blood samples will be collected every 2 weeks for the first 6 months. Bone marrow samples will be collected at 3 and 6 months. These samples will look at the effects of the study drug on the marrow. * Participants will continue to take the study drug for as long as it is effective and if the side effects are not severe.
Primary Outcome
Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was \<9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by a
Interventions
- DRUG Eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-06-28 |
| Est. Completion | 2022-08-24 |
| Phase | Phase 2 |
What the finished NCT01891994 record still lists
NCT01891994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Eltrombopag is the first listed.
NCT01891994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01891994 about?
NCT01891994 is a clinical study titled "Extended Dosing With Eltrombopag for Severe Aplastic Anemia". Background: \- Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help improve blood counts in these patients. However, researchers do not know how long the drug can and should be taken for this type of anemia. Objectives: \- To look at whether 6 months of treatment wi...
What is the current status of trial NCT01891994?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-06-28. Estimated completion is 2022-08-24.
What interventions are being tested in trial NCT01891994?
The interventions under investigation include: Eltrombopag (DRUG).
Who is sponsoring clinical trial NCT01891994?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01891994's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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