UAB has enrolled the first U.S. patient in a Phase III clinical trial for a drug that, if successful, would be a significant clinical breakthrough for reducing pre-term births and infant mortality.
In the randomized, double-blind, placebo-controlled PRESERVE-1 trial, ATryn®, or antithrombin recombinant, will be administered to treat preeclampsia during weeks 24-28 of pregnancy to assess whether it prolongs pregnancy in mothers with this condition.
Preeclampsia is characterized by high blood pressure and damage to another organ system, often the kidneys, that usually begins after 20 weeks of pregnancy in women whose blood pressure had previously been normal. If left untreated, it can lead to serious — even fatal — complications for mother and baby.
“Currently, when patients have preeclampsia, all we have to offer is delivery of the baby as the ultimate treatment,” said Alan Tita, M.D., Ph.D., professor of Obstetrics and Gynecology and a lead investigator for the trial.
“I see firsthand the significant need for new medicines to safely extend pregnancy and give a baby more time to develop in utero,” Tita said. “PRESERVE-1 is an important Phase III trial to assess the potential benefits of ATryn in a clear area of unmet medical need.”
UAB is expected to be a leader in the trial, which will enroll 120 women at centers around the country during the next 18 months. Physicians and health professionals can refer patients by calling UAB Medical Information Service via Telephone, a 24-hour service, at 205-934-6478 or 1-800-UAB-MIST.
See the full story and a video interview at UAB News.