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NCT00678587 · ClinicalTrials.gov registry record · Phase 3

Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures

A Phase 3 study, sponsored by GlaxoSmithKline.

Terminated
Registry status
Phase 3
Development phase
292
Enrollment target

NCT00678587: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.

NCT00678587 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 292 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00678587, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.

TERMINATED
Registry status
Phase 3
Development phase
292 participants
Enrollment target

Study Summary

The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

Primary Outcome

A platelet transfusion was given if the platelet count was \<50 giga (10\^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was \>80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.

Interventions

  • DRUG Placebo
  • DRUG Eltrombopag

Trial Details

FieldValue
Enrollment Target 292 participants
Start Date 2008-06
Est. Completion 2009-10
Phase Phase 3
GlaxoSmithKline

1,345 total trials

Why NCT00678587 stopped before completion

NCT00678587 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00678587 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00678587 about?

NCT00678587 is a clinical study titled "Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures". The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by th...

What is the current status of trial NCT00678587?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 292 participants. The study started on 2008-06. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00678587?

The interventions under investigation include: Placebo (DRUG), Eltrombopag (DRUG).

Who is sponsoring clinical trial NCT00678587?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00678587's enrollment target sits among peer trials

292 1166th of 2000 higher than 833 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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Source: ClinicalTrials.gov NCT00678587, the US trial registry maintained by the National Library of Medicine. NCT00678587 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.