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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Thrombocytopenia
Drug: Eltrombopag
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: August 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Eltrombopag
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194167

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
GlaxoSmithKline
Investigators
Principal Investigator: Patricia Carey, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01194167     History of Changes
Other Study ID Numbers: UCC-H1
Study First Received: August 25, 2010
Last Updated: January 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Platelet refractory thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014