Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Phase 2WithdrawnNCT01194167

University of Cincinnati

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Thrombocytopenia

Interventions

EltrombopagDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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