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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This study has been withdrawn prior to enrollment.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

August 25, 2010
January 8, 2012
August 2010
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01194167 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Eltrombopag in Platelet Refractory Thrombocytopenia
A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thrombocytopenia
Drug: Eltrombopag
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day
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.
Intervention: Drug: Eltrombopag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01194167
UCC-H1
Not Provided
University of Cincinnati
University of Cincinnati
GlaxoSmithKline
Principal Investigator: Patricia Carey, MD University of Cincinnati
University of Cincinnati
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP