drugset / Trial / NCT01621204
A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients
Phase 3
Completed
74 enrolled
McMaster University
GlaxoSmithKline · collabHamilton Health Sciences Corporation · collabNovartis · collab
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
Publications
- Results Arnold DM, Heddle NM, Cook RJ, Hsia C, Blostein M, Jamula E, Sholzberg M, Lin Y, Kassis J, Larratt L, Tinmouth A, Amini S, Schipperus M, Lim W, Vishnu P, Warner M, Carruthers J, Li N, Lane S, Kelton JG. Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial. Lancet Haematol. 2020 Sep;7(9):e640-e648. doi: 10.1016/S2352-3026(20)30227-1.
- Arnold DM, Jamula E, Heddle NM, Cook RJ, Hsia C, Sholzberg M, Lin Y, Kassis J, Blostein M, Larratt L, Amini S, Schipperus M, Carruthers J, Lane SJ, Li N, Kelton JG. Peri-Operative Eltrombopag or Immune Globulin for Patients with Immune Thrombocytopaenia (The Bridging ITP Trial): Methods and Rationale. Thromb Haemost. 2019 Mar;119(3):500-507. doi: 10.1055/s-0038-1677531. Epub 2019 Jan 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |