Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
Public ClinicalTrials.gov record NCT02059135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Randomized Double-Blind, Placebo Controlled Evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia (PRESERVE-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02059135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- Recombinant human antithrombin (ATryn) Biological
- Normal Saline 0.9% Other
Biological · Other
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 11, 2014 (Actual)
- Primary completion
- May 18, 2016 (Actual)
- Completion
- Nov 2016 (Actual)
- Last update posted
- Aug 9, 2017
2014 – 2016
United States locations
- U.S. sites
- 23
- U.S. states
- 19
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35210 | — |
| University of South Alabama | Mobile | Alabama | 36604 | — |
| University of Arkansas | Little Rock | Arkansas | 72204 | — |
| University of California at Irvine | Orange | California | 92868 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Norton Healthcare | Louisville | Kentucky | 40202 | — |
| Oschner Baptist | New Orleans | Louisiana | 70112 | — |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 32916 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Saint Louis University School of Medicine | St Louis | Missouri | 63117 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Tri-State Maternal Fetal Health | Cincinnati | Ohio | 45211 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Women & Infants Hospital | Providence | Rhode Island | 02905 | — |
| Erlanger Medical Center | Chattanooga | Tennessee | 347403 | — |
| University Texas Medical Branch | Galveston | Texas | 77555 | — |
| University of Texas Houston School of Medicine | Houston | Texas | 77030 | — |
| Intermountain Health | Murray | Utah | 84107 | — |
| University of Utah Hospitals & Clinics | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02059135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02059135 live on ClinicalTrials.gov.