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Lupus Clinical Trials

New Medical Therapies™

Pregnancy Complications

April 28, 2008

GlaxoSmithKline and Protherics reported mixed results from a phase IIb trial of Digibind for the treatment of pre-eclampsia. This parallel-group, double-blind, placebo-controlled, randomized study was dubbed DEEP (Digoxin Immune Fab (DIF) Efficacy Evaluation in Pre-eclampsia). It enrolled fifty-one women with severe pre-eclampsia who were in the twenty-fourth through thirty-fourth week of pregnancy, and for whom delivery of the baby was considered necessary within seventy-two hours. The subjects received either Digibind or placebo every six hours for up to forty-eight hours. The two primary endpoints were creatinine clearance, a measure of kidney function, and the use of antihypertensive medication to lower blood pressure. The DEEP study met the first endpoint; the deterioration in kidney function during the 24-48 hours period of treatment was significantly less (p<0.05) in subjects receiving Digibind compared to subjects receiving placebo. However, there was no significant difference for the other primary endpoint, the use of antihypertensive drugs. Based on the results the companies planned to conduct a full analysis of the data in order to determine the future course of action.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.