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EXTEND (Eltrombopag Extended Dosing Study)

NCT00351468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2017-04-17

Study results available
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Summary

An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.

Conditions

  • Purpura, Thrombocytopaenic, Idiopathic

Interventions

DRUG

eltrombopag olamine (SB-497115-GR)

Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Netherlands
  • New Zealand
  • Pakistan
  • Peru
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Tunisia
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

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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 NCT00351468 on ClinicalTrials.gov