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NCT01054443 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
A Phase 2 study, sponsored by Shionogi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01054443: Clinical Trial Phase 2 study, sponsored by Shionogi.
NCT01054443 is a Phase 2 study that was terminated before completion, run by Shionogi. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01054443, a Phase 2 study, was terminated before completion, sponsored by Shionogi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
Primary Outcome
Responders were participants with one of the following: 1. achieved a platelet count of ≥ 50,000 cells/µL after 6 weeks of dosing; or 2. prematurely withdrawn due to a platelet count \> 400,000 cells/µL prior to Day 42. Participants were counted as non-responders if any of the following conditions held: * The above conditions were not satisfied; * They received rescue medications; * They satisfied the above conditions after receiving restricted medications during the treatment period; * They
Interventions
- DRUG Placebo
- DRUG Lusutrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-03-18 |
| Est. Completion | 2010-11-24 |
| Phase | Phase 2 |
Why NCT01054443 stopped before completion
NCT01054443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01054443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01054443 about?
NCT01054443 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)". The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
What is the current status of trial NCT01054443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-03-18. Estimated completion is 2010-11-24.
What interventions are being tested in trial NCT01054443?
The interventions under investigation include: Placebo (DRUG), Lusutrombopag (DRUG).
Who is sponsoring clinical trial NCT01054443?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01054443's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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