Study of Eltrombopag in Platelet Refractory Thrombocytopenia

University of Cincinnati

Status and phase: Withdrawn; Phase 2

Conditions: Thrombocytopenia

Treatments: Drug: Eltrombopag

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01194167

UCC-H1

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Eltrombopag

Experimental group

Description:

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.

Treatment:

Drug: Eltrombopag