Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Thrombocytopenia Clinical Trial

Official title:

A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01194167
• Other study ID #: UCC-H1
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombocytopenia

Intervention

Drug:
• Eltrombopag
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 years average