Pregnancy Complications

March 5, 2018

Geneva reported positive top line results of the IMPLANT2 Phase III clinical trial of its oral oxytocin receptor antagonist, nolasiban , which is being developed for improving pregnancy rates following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures. IMPLANT2 is a Phase III, randomized, double blind, clinical trial assessing nolasiban compared to placebo for improving the rate of pregnancy in patients undergoing IVF or ICSI due to low fertility. The Phase III trial included 778 patients from across nine countries. Following ovarian stimulation, egg retrieval and fertilization, eligible women were randomized to receive either a single, oral dose of 900 mg nolasiban or placebo four hours before D3 or D5 fresh, single ET. Patients received either a single 900 mg dose of nolasiban or placebo (1:1) orally on the day of embryo transfer (ET). The primary endpoint of the clinical trial was met, with an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1 percent (placebo 28.5 percent and nolasiban 35.6 percent, p = 0.031). This represents a relative increase of 25 percent in the ongoing pregnancy rate after administration of nolasiban compared to placebo.

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.