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

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 11, 2014

Primary Completion Date

May 18, 2016

Study Completion Date

November 30, 2016

Conditions
Preeclampsia
Interventions
BIOLOGICAL

Recombinant human antithrombin (ATryn)

Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days

OTHER

Normal Saline 0.9%

Placebo Comparator: Normal Saline 0.9%

Trial Locations (23)

10032

Columbia University Medical Center, New York

27705

Duke University, Durham

32916

University of Mississippi Medical Center, Jackson

33606

University of South Florida, Tampa

35210

University of Alabama, Birmingham

36604

University of South Alabama, Mobile

40202

Norton Healthcare, Louisville

45211

Tri-State Maternal Fetal Health, Cincinnati

48236

Saint John Hospital and Medical Center, Detroit

60611

Northwestern University, Chicago

63110

Barnes-Jewish Hospital, St Louis

63117

Saint Louis University School of Medicine, St Louis

70112

Oschner Baptist, New Orleans

72204

University of Arkansas, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

University of Texas Houston School of Medicine, Houston

77555

University Texas Medical Branch, Galveston

84107

Intermountain Health, Murray

84132

University of Utah Hospitals & Clinics, Salt Lake City

92868

University of California at Irvine, Orange

347403

Erlanger Medical Center, Chattanooga

06519

Yale New Haven Hospital, New Haven

02905

Women & Infants Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

rEVO Biologics

INDUSTRY

NCT02059135 - Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia | Biotech Hunter | Biotech Hunter