Study of Eltrombopag in Platelet Refractory Thrombocytopenia

This study has been withdrawn prior to enrollment.

(Inability to identify eligible patients)

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

University of Cincinnati

ClinicalTrials.gov Identifier:

NCT01194167

First received: August 25, 2010

Last updated: January 8, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 25, 2010

Last Updated Date

January 8, 2012

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the likelihood of eltrombopag allowing platelet transfusion independence in patients with platelet refractoriness at doses of 75 mg, 150 mg, and 300 mg per day [ Time Frame: 3 years average ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01194167 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Official Title ^ICMJE

A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Brief Summary

This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Thrombocytopenia

Intervention ^ICMJE

Drug: Eltrombopag

75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day

Study Arm (s)

Experimental: Eltrombopag

Eltrombopag 75 mg per day. Possible escalation to 150 mg per day after day 15 lab results. Possible escalation to 300 mg per day after day 29 lab results.

Intervention: Drug: Eltrombopag

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Laboratory diagnosis of platelet refractoriness
Diagnosis of platelet dependence
Adequate liver and renal laboratory screening tests

Exclusion Criteria:

Patients with thrombocytopenia that are responsive to platelet therapy
Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01194167

Other Study ID Numbers ^ICMJE

UCC-H1

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Cincinnati

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Patricia Carey, MD

University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top