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NCT01433978 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
A Phase 3 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT01433978: Clinical Trial Phase 3 study, sponsored by Eisai.
NCT01433978 is a Phase 3 study that was terminated before completion, run by Eisai. 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
NCT01433978, a Phase 3 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
Core study: To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura \[ITP\]) as measured by durable platelet response. Open-label Extension Phase: To evaluate the safety and tolerability of long-term therapy with avatrombopag in participants with chronic ITP (cITP).
Primary Outcome
Platelet responses to avatrombopag was evaluated using the platelet counts determined at local clinical laboratories. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics. Standard deviation is not applicable for some of the categories, from Visit 14 to Visit 22, as the number of participants analyzed for that visit was 1 individual.
Interventions
- DRUG Eltrombopag
- DRUG Standard of care
- DRUG Avatrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-03-26 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
Why NCT01433978 stopped before completion
NCT01433978 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 3 interventions - of which Eltrombopag is the first listed.
NCT01433978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01433978 about?
NCT01433978 is a clinical study titled "A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)". Core study: To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura \[ITP\]) as measured by durable platelet response....
What is the current status of trial NCT01433978?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2012-03-26. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01433978?
The interventions under investigation include: Eltrombopag (DRUG), Standard of care (DRUG), Avatrombopag (DRUG).
Who is sponsoring clinical trial NCT01433978?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01433978'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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