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NCT01880047 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Eltrombopag at Escalated Doses
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01880047: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT01880047 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01880047, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP there are some patients who have been reported as non responders at the maximal approved dose of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously published data has shown no overt increase in toxicity in normal volunteers, oncology patients and aplastic anemia patients treated with escalated doses as high or higher than those proposed in this study. It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily, eltrombopag could be more effective at a higher dose. We propose a double blind randomized controlled trial in ITP patients who have been defined as non-responders at the maximum dose (75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg, 150 mg)
Primary Outcome
To determine if patients with chronic ITP who do not respond to 75 mg of eltrombopag daily given for at least 3 weeks but then do respond to eltrombopag given daily first for 2 weeks at doses of 100, then for 2 weeks at 125 mg and finally for 4 weeks at a dose of 150mg daily. Response will be defined as 2 consecutive platelet counts of \> 50,000 with an increase of \> 20,000 from the study baseline within the 8 week increased dose window not as a result of rescue treatment.
Interventions
- DRUG Placebo
- DRUG Eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-02 |
| Est. Completion | 2017-10-16 |
| Phase | Phase 2 |
What the finished NCT01880047 record still lists
NCT01880047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01880047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01880047 about?
NCT01880047 is a clinical study titled "Safety and Efficacy of Eltrombopag at Escalated Doses". Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP there are some patients who have been reported as non responders at the maximal approved dose of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and increasing response rate...
What is the current status of trial NCT01880047?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2013-02. Estimated completion is 2017-10-16.
What interventions are being tested in trial NCT01880047?
The interventions under investigation include: Placebo (DRUG), Eltrombopag (DRUG).
Who is sponsoring clinical trial NCT01880047?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01880047's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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