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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 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 35 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01880047
The ClinicalTrials.gov registry entry for NCT01880047 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01880047 reports 0 study locations.
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.
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