drugset / Trial / NCT01621204

A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients

NCT01621204

RandomizedParallel-groupOpen-labelSupportive care

Summary

This is a study to investigate if eltrombopag can be used instead of Intravenous Immune Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need surgery have to get treatment to increase their platelet count. IVIG is commonly used for this purpose but eltrombopag may be more effective and convenient for patients.

Timeline

Start
2012-10
Primary completion
2019-06
Completion
2019-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Eltrombopag Small molecule 25 mg Oral
Subject Eltrombopag Small molecule 50 mg Oral
Subject Eltrombopag Small molecule 75 mg Oral
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 1 g/kg Intravenous
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous