drugset / Trial / NCT00111475
Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
RandomizedSequentialDouble-blindTreatment
Summary
The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.
Timeline
- Start
- 2002-07-01
- Primary completion
- 2004-06-17
- Completion
- 2004-06-17
Publications
- Background Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14.
- Background Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006 Oct 19;355(16):1672-81. doi: 10.1056/NEJMoa054626.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romiplostim | Peptide | 0.2 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 0.5 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 1 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 3 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 6 ug/kg | Subcutaneous |
| Subject | Romiplostim | Peptide | 10 ug/kg | Subcutaneous |