Date: 2014-07-23
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: rEVO Biologics (USA - MA) an LFB Company (France)
Product: ATryn® (antithrombin alfa)
Action mechanism:
Disease: preeclampsia
Therapeutic area: Women health
Country: USA
Trial
details: PRESERVE-1 (Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia) is a Phase 3, randomized, double-blind, placebo-controlled trial of 120 patients assessing the safety, efficacy and pharmacokinetics of ATryn®, in patients who are being expectantly managed for early onset preeclampsia.
Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby for women given ATryn® to those given placebo. The effect of ATryn® on neonatal clinical outcomes will also be assessed. (NCT02059135)
Latest
news: * On July 23, 2014, rEVO Biologics, a subsidiary of LFB Biotechnologies, announced the enrollment of the first patient in its Phase 3 clinical trial of ATryn® [antithrombin], for the treatment of preeclampsia during the 24th to 28th week of pregnancy, or early onset preeclampsia. The objective of the PRESERVE-1 trial is to assess whether ATryn® prolongs pregnancy in mothers with early onset preeclampsia, consequently reducing the high rates of neonatal mortality and disability caused by this condition.
The first patient was enrolled by Alan Tita, M.D., Ph.D., Professor of Obstetrics and Gynecology and his team at the University of Alabama, Birmingham. The primary objective of the PRESERVE-1 randomized double-blind, placebo-controlled trial is to assess the efficacy, safety and pharmacokinetics of ATryn for the treatment of early onset preeclampsia when used together with expectant management, the current standard of care. Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby in women given ATryn to those given placebo. The effect of ATryn on neonatal clinical outcomes will also be assessed. This trial is currently enrolling patients in the United States.
