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NCT01520909 · ClinicalTrials.gov registry record · Phase 3
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 92
- Enrollment target
NCT01520909: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01520909 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 92 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01520909, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 92 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.
Primary Outcome
Participants who achieved a platelet count \>=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported.
Interventions
- DRUG Placebo
- DRUG Eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01520909 record still lists
NCT01520909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01520909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01520909 about?
NCT01520909 is a clinical study titled "Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.". The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or ...
What is the current status of trial NCT01520909?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 92 participants. The study started on 2012-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01520909?
The interventions under investigation include: Placebo (DRUG), Eltrombopag (DRUG).
Who is sponsoring clinical trial NCT01520909?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01520909's enrollment target sits among peer trials
92 1723rd of 2000 higher than 277 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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