Clinical trialNCT02059135CompletedPhase 3Interventional

Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia

SponsorrEVO BiologicsEnrollment120Preeclampsia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of the study is to assess the efficacy, safety and pharmacokinetics (PK) of recombinant human antithrombin (ATryn) in addition to expectant management for the treatment of preterm preeclampsia (PPE). Efficacy will be assessed by comparing the difference in extension of gestational age from the time of randomization into the study until delivery between ATryn and placebo treated subjects. In addition, the effect of ATryn on fetal and neonatal clinical outcomes will be assessed. The PK characteristics of ATryn in the subjects will be investigated by measuring AT activity levels in the mother during treatment and in cord blood.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Michael Paidas, MD
Yale New Haven Hospital
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
University of Arkansas
Little Rock, Arkansas, United States
University of California at Irvine
Orange, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Norton Healthcare
Louisville, Kentucky, United States
Oschner Baptist
New Orleans, Louisiana, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Saint Louis University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Tri-State Maternal Fetal Health
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Women & Infants Hospital
Providence, Rhode Island, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
University Texas Medical Branch
Galveston, Texas, United States
University of Texas Houston School of Medicine
Houston, Texas, United States
Intermountain Health
Murray, Utah, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Recombinant human antithrombin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Jul 2014
Primary completion: 18 May 2016
Completion: 30 Nov 2016
Last update posted: 9 Aug 2017
Registered enrollment: 120
Registry id: NCT02059135

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.