Belatacept in Liver Transplant Recipients

Phase 2 Terminated 260 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

Timeline

Start: 2008-01
Primary completion: 2010-03
Completion: 2011-06

Publications

Klintmalm GB, Feng S, Lake JR, Vargas HE, Wekerle T, Agnes S, Brown KA, Nashan B, Rostaing L, Meadows-Shropshire S, Agarwal M, Harler MB, Garcia-Valdecasas JC. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. Am J Transplant. 2014 Aug;14(8):1817-27. doi: 10.1111/ajt.12810.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous
Subject	Tacrolimus	Small molecule	—	Oral
Background	Basiliximab	Monoclonal antibody	20 mg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1 g	Intravenous
Background	Mycophenolate Mofetil	Small molecule	2 g	Intravenous

Belatacept in Liver Transplant Recipients

Summary

Timeline

Publications

Drugs

Indications