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

Completed · Phase 3 · Has a placebo group

Conditions studied: Preeclampsia

In brief

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.

Key facts

Study ID: NCT02059135
Run by: rEVO Biologics
People needed: 120
Starts: 2014-07-11
Expected to finish: 2016-11-01
Last updated by the study team: 2017-08-09

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Hospitalized female pregnant patients of gestational age of ≥23 0/7 weeks to ≤30 0/7 weeks (for subjects at gestational age 23 0/7 to 23 6/7 all standard interventions including antenatal steroids and cesarean for fetal indications must be offered).
Gestational age determination by local practice using one of the following three approaches:
Last menstrual period (LMP) dating and confirmatory ultrasound
Ultrasound alone when LMP is not reliable
Known date of conception in the setting of assisted reproductive technology
At least 16 years of age (NOTE: different age restrictions may apply per local regulation and/or ethical considerations; subjects under the local age of consent may be excluded at the discretion of the reviewing Institutional Review Board (IRB)
Recent diagnosis of Preeclampsia or Superimposed Preeclampsia as defined by:
For Preeclampsia
Gestational hypertension defined as a recorded systolic blood pressure (BP) of
≥140 mm Hg or diastolic BP of ≥90 mm Hg on 2 occasions at least 4 hours apart (since the commencement of medical intervention in any facility) OR
Severe gestational hypertension defined as systolic blood pressure of ≥ 160 mm Hg or diastolic blood pressure ≥ 110 mm Hg, confirmed with second assessment within a short interval (minutes) AND
New onset of any of the following:
Proteinuria defined as ≥0.3 g protein per 24 hours in a 12-24 hour urine collection or protein/creatinine ratio of ≥0.3 mg/mg* (on a random sample or any collection period.)
Platelet count less than 100,000/μL
Serum creatinine concentrations greater than 1.1 mg/dL in the absence of other renal disease
Elevated liver transaminases to ≥ twice upper limit of normal
Cerebral or visual symptoms
For Superimposed preeclampsia:
The start of antihypertensive medication, increasing the dose of a currently administered antihypertensive medication or adding a second antihypertensive medication after 20 weeks of pregnancy for systolic BP ≥ 160 or diastolic BP ≥ 105 in a patient that had a previous history of controlled hypertension before 20 weeks of pregnancy. AND
New onset of any of the following:
proteinuria defined as ≥0.3 g protein per 24 hours in a 12-24 hour urine collection or protein/creatinine ratio of ≥0.3 mg/mg (on a random sample or any collection period)
Platelet count less than 100,000/μL
Serum creatinine concentrations greater than 1.1 mg/dL in the absence of other renal disease
Elevated liver transaminases to ≥ twice upper limit of normal
Cerebral or visual symptoms

You may not qualify if…

Criteria that would likely require immediate delivery of the fetus are exclusionary if present just prior to randomization:
Refractory hypertension despite maximal medical intervention of systolic BP ≥160 mm Hg or diastolic BP of ≥110 mm Hg
Thrombocytopenia (platelets ˂ 100/mm3) with or without Hemolysis elevated liver enzymes low platelets (HELLP) syndrome defined as defined as Aspartate amino transferase (AST) ≥70 units/L, and platelets ˂100/mm3, and evidence of hemolysis on blood film plus either Lactic dehydrogenase (LDH) ≥600 IU/mL or total bilirubin ≥1.2 mg/dL)
Oliguria (≤500 mL/24 hours) or evidence of progressive renal insufficiency
Serum creatinine concentration greater than 1.1 mg/dL
Persistent visual disturbances
Placental abruption
Pulmonary edema
Nonreassuring fetal heart rate tracing
Intractable headache unrelieved with analgesia
Intractable right upper quadrant abdominal pain or vomiting
If umbilical Doppler ultrasound has been performed, the presence of an abnormal umbilical artery Doppler as defined by absent or reverse end diastolic flow
Biophysical score ≤ 4/10 on 2 occasions
Oligohydramnios (deepest vertical pocket less than 2 x 2cm on ultrasound)
Other maternal or fetal conditions that would preclude expectant management
Known lethal or major fetal anomaly
Recent (within 12 months) history of maternal alcoholism or drug dependence
Diagnosis of epilepsy
Has need for chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase (Cox)-2 inhibitors, or unwilling to abstain from use of NSAIDs during the study treatment period (low dose aspirin of 81 mg/day or less allowable)
Received within 72 hours or has requirement for heparin; low molecular weight heparins such as enoxaparin or dalteparin; fondaparinux; antiplatelet agents such as clopidogrel, prasugrel, or high dose aspirin (>81 mg/day); Direct Thrombin Inhibitors (DTI) such as dabigatran
Pre-existing renal disease, documented pre-pregnancy or in pregnancy prior to 20 weeks gestation (prior to the diagnosis of preeclampsia) or 24 hr urine of ≥0.3 gm/24 hours, documented in pregnancy, prior to 20 weeks gestation or ≥2+ dipstick or ≥ 0.3 Protein Creatinine Ratio (PCR), documented in pregnancy at the last available test prior to 20 weeks gestation. In the case of conflicting results between dipstick, PCR, and timed urine collection tests to work up an episode of proteinuria, the timed urine collection result would supersede other results
Multi-fetal pregnancy
History of Antiphospholipid antibody syndrome
Known hypersensitivity to goat and goat milk proteins
Participation in another interventional clinical trial of an investigational, unapproved therapy (drug, biologic, device) within 30 days of consent

Where it is running

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

Full record on ClinicalTrials.gov

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