Eltrombopag and High-dose Dexamethasone as First Line Treatment for IT
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|ClinicalTrials.gov Identifier: NCT01652599|
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : January 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenic Purpura||Drug: Eltrombopag and dexamethasone||Phase 2|
Immune Thrombocytopenia is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction.
Corticosteroids increase the platelet count in about 80 percent of patients.However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Eltrombopag, it is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin, has been shown to be effectively raise the platelet count in adult patients (aged 18 years and over) who have had their spleen removed or where splenectomy is not an option and have received prior treatment with corticosteroids or immunoglobulins, and these medicines did not work (refractary ITP). There are a few case reports where eltrombopag was an option as first line treatment for IT.
The purpose of this study is to determine the response rate and response duration with the combination of eltrombopag (50mg PO once a day for 4 weeks) and high-dose dexamethasone (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic or in patients with less than 7 days of treatment with corticosteroids.
A complete platelet response is defined as an increase in platelet counts to >150×109/L on two consecutive occasions. A partial response is defined as an increase in the platelet count to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response is considered from the day of the initial administration to the first time of relapse (platelet count <30×109/L)or to time of analysis.
At the end of the first 5 weeks, the patients will followed by 6 months every month.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Eltrombopag and High-dose Dexamethasone as First Line Treatment for Immune Thrombocytopenia|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||November 2013|
|Experimental: Eltrombopag and dexamethasone||
Drug: Eltrombopag and dexamethasone
Eltrombopag 50 mg PO days 5-32 Dexamethasone 40 mg PO days 1-4
Other Name: Revolade
- Number of patients with sustained response after 6 months [ Time Frame: 6 months ]Number of patients with complete response at month 6
- Number of patients with complete response at month 6 [ Time Frame: month 6 ]Number of patients with platelet count at least 150x109/L, 6 months after therapy
- Bleeding [ Time Frame: month 6 ]Number of patients with bleeding complication therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652599
|Hospital Universitario "Dr. Jose E. Gonzalez" UANL|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Principal Investigator:||David Gomez-Almaguer, MD||Hospital Universitario Dr. Jose E. Gonzalez|