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A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

NCT01098487 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2015-03-12

Study results available
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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.

Conditions

  • Purpura, Thrombocytopaenic, Idiopathic

Interventions

DRUG

Eltrombopag olamine

Thrombopoietin receptor agonist

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Pakistan
  • Russia
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098487 on ClinicalTrials.gov