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NCT01098487 · ClinicalTrials.gov registry record · Phase 4
A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 167
- Enrollment target
NCT01098487: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01098487 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 167 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01098487, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 167 participants
- Enrollment target
Study Summary
A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.
Primary Outcome
The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis \[MF\]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersec
Interventions
- DRUG Eltrombopag olamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT01098487 record still lists
NCT01098487 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Eltrombopag olamine is the first listed.
NCT01098487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01098487 about?
NCT01098487 is a clinical study titled "A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)". A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe t...
What is the current status of trial NCT01098487?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 167 participants. The study started on 2010-05. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01098487?
The interventions under investigation include: Eltrombopag olamine (DRUG).
Who is sponsoring clinical trial NCT01098487?
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 NCT01098487's enrollment target sits among peer trials
167 488th of 2000 higher than 1,512 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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