Study of Eltrombopag in Platelet Refractory Thrombocytopenia

NCT ID: NCT01194167

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Eltrombopag

Intervention Type DRUG

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

Interventions

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Eltrombopag

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Carey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UCC-H1

Identifier Type: -

Identifier Source: org_study_id

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