Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers

Phase 2 Completed 23 enrolled Susan P. Perrine Boston Medical Center · collab Icahn School of Medicine at Mount Sinai · collab Schneider Children's Medical Center, Israel · collab University of Illinois at Chicago · collab University of Tennessee · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.

Timeline

Start: 1997-09
Primary completion: 2002-12
Completion: 2005-02

Publications

Results McMahon L, Tamary H, Askin M, Adams-Graves P, Eberhardt RT, Sutton M, Wright EC, Castaneda SA, Faller DV, Perrine SP. A randomized phase II trial of Arginine Butyrate with standard local therapy in refractory sickle cell leg ulcers. Br J Haematol. 2010 Dec;151(5):516-24. doi: 10.1111/j.1365-2141.2010.08395.x. Epub 2010 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Arginine Butyrate	Small molecule	500 mg/kg	Intravenous
Subject	Arginine Butyrate	Small molecule	750 mg/kg	Intravenous

Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers

Summary

Timeline

Publications

Drugs

Indications