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NCT00625443 · ClinicalTrials.gov registry record · Phase 2
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT00625443: Completed Phase 2 study, sponsored by Eisai.
NCT00625443 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00625443, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).
Primary Outcome
A TEAE was defined as 1) the AE started on or after the date of first dose of study drug up to and including 30 days after the last dose of study drug, or 2) the AE started before the first dose of study drug but worsened in severity on or after the date of first dose of study drug up to and including 3 days after the last dose of study drug. For participants having a tapering period of study drug, the last dose day is the last day of study drug during the tapering period. Related AEs included t
Interventions
- DRUG Blinded (placebo)
- DRUG Open Label (Avatrombopag tablets)
- DRUG Blinded (Avatrombopoag tablets)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00625443 record still lists
NCT00625443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Blinded (placebo) is the first listed.
NCT00625443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00625443 about?
NCT00625443 is a clinical study titled "Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003". The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).
What is the current status of trial NCT00625443?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2007-05. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00625443?
The interventions under investigation include: Blinded (placebo) (DRUG), Open Label (Avatrombopag tablets) (DRUG), Blinded (Avatrombopoag tablets) (DRUG).
Who is sponsoring clinical trial NCT00625443?
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 NCT00625443's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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