PreeclampsiaPhase 3PRESERVE-1NCT02059135
Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
A Phase 3 study testing Recombinant human antithrombin (ATryn) and Normal Saline 0.9% in people with Preeclampsia, run by rEVO Biologics at 23 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Recombinant human antithrombin (ATryn) and Normal Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 23 sitesUnited States
- Study dates
- 11 Jul 2014to Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 28Show fewer
- 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
- In the opinion of the investigator the patient has demonstrated sufficient clinical stability to be eligible for expectant management
- The patient is expected to be managed as an inpatient until delivery
- Signed informed consent for both subject and neonate
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Alabama
Birmingham, Alabama, 35210
Erlanger Medical Center
Chattanooga, Tennessee, 347403
Northwestern University
Chicago, Illinois, 60611
Tri-State Maternal Fetal Health
Cincinnati, Ohio, 45211
Saint John Hospital and Medical Center
Detroit, Michigan, 48236
Duke University
Durham, North Carolina, 27705
University Texas Medical Branch
Galveston, Texas, 77555
University of Texas Houston School of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 32916
University of Arkansas
Little Rock, Arkansas, 72204
Norton Healthcare
Louisville, Kentucky, 40202
University of South Alabama
Mobile, Alabama, 36604
Intermountain Health
Murray, Utah, 84107
Yale New Haven Hospital
New Haven, Connecticut, 06519
Oschner Baptist
New Orleans, Louisiana, 70112
Columbia University Medical Center
New York, New York, 10032
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of California at Irvine
Orange, California, 92868
Women & Infants Hospital
Providence, Rhode Island, 02905
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84132
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Saint Louis University School of Medicine
St Louis, Missouri, 63117
University of South Florida
Tampa, Florida, 33606
About this study
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)
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.
Read the detailed description
Hospitalized PPE patients who are being expectantly managed, after initial assessment and stabilization period, will be considered for the study. After informed consent has been obtained subjects will be screened for eligibility. Screening includes obtaining the subject's medical/obstetric history and a physical examination which includes an assessment of maternal and fetal status. Blood samples for hematology, clinical chemistries, biomarkers, coagulation, immunogenicity and AT activity levels will be drawn. Urine will be collected for baseline urinalysis, protein/creatinine ratio and biomarkers. Eligible subjects who meet inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive a continuous infusion of either ATryn or placebo.
Sampling for AT activity will be performed immediately prior to the first dose of study drug and at specified times thereafter.
Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation. The average extension of pregnancy with standard of care expectant management in this patient population is approximately 7 days. It is assumed that treatment with ATryn will provide an additional increase in gestational age of 5-7 days as compared to this standard of care. Total duration on study drug is therefore estimated to be approximately 7 to 14 days on average.
Post treatment assessments of the mother will be performed at hospital discharge and approximately 4-6 weeks after delivery of the neonate. Information on the neonates will be collected until they reach a post-menstrual age (PMA) of 36 weeks. If the neonate reaches 36 weeks PMA < 28 days following delivery, the final neonatal follow-up visit should be done at the 4-6 week post-delivery visit.
After the primary study completion and follow-up period, the neonate total number of days in the Neonatal Intensive Care Unit (NICU), days on a ventilator, days requiring supplemental oxygen (FiO2 ≥21%),the neonate hospital discharge date and whether the neonate is discharged from the hospital with a requirement for supplemental home oxygen therapy will be collected to help assess health care utilization. In addition, the date of death will be collected if the neonate expires before hospital discharge. These data will be considered supplemental to the primary study data set.
- Conditions
- Preeclampsia
- Being tested
- Recombinant human antithrombin (ATryn), Normal Saline 0.9%
- Keywords
- Preeclampsia, Preterm preeclampsia, Pregnancy
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human antithrombin (ATryn)Biological
Also called Recombinant human antithrombin (rhAT)
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
Normal Saline 0.9%Other
Also called Normal Saline
Placebo Comparator: Normal Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Antithrombin (ATryn) | Active comparator | 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 Receives: Biological: Recombinant human antithrombin (ATryn) |
| Normal Saline 0.9% | Placebo comparator | Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. Receives: Other: Normal Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Gestational Age in Days
Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.
Measured: Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.
Secondary outcomes (1)
Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)
Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once.
Score Outcome 0 No events, no mortality
- One event, no mortality
- Two events, no mortality
- Three or more events, no mortality
- Death
Measured: Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start11 Jul 2014
- Primary completion18 May 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- rEVO Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Paidas, MD, Principal investigator, Yale New Haven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059135
- Sponsor's protocol ID
- RB AT PPE 01-13
- Acronym
- PRESERVE-1
- Status last verified
- Jul 2017
- First submitted
- 6 Feb 2014
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Paidas MJ, Tita ATN, Macones GA, Saade GA, Ehrenkranz RA, Triche EW, Streisand JB, Lam GK, Magann EF, Lewis DF, Dombrowski MP, Werner EF, Branch DW, Habli MA, Grotegut CA, Silver RM, Longo SA, Amon E, Cleary KL, How HY, Novotny SR, Grobman WA, Whiteman VE, Wing DA, Scifres CM, Sibai BM. Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia. Am J Obstet Gynecol. 2020 Nov;223(5):739.e1-739.e13. doi: 10.1016/j.ajog.2020.08.004. Epub 2020 Aug 8.
PubMed 32780999Cotten CM. Adverse consequences of neonatal antibiotic exposure. Curr Opin Pediatr. 2016 Apr;28(2):141-9. doi: 10.1097/MOP.0000000000000338.
PubMed 26886785
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02059135
- Acronym / sponsor ID
- PRESERVE-1 / RB AT PPE 01-13
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Preterm preeclampsia, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- rEVO BiologicsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2014 (actual)
- Primary completion
- 18 May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 9 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hospitalized PPE patients who are being expectantly managed, after initial assessment and stabilization period, will be considered for the study. After informed consent has been obtained subjects will be screened for eligibility. Screening includes obtaining the subject's medical/obstetric history and a physical examination which includes an assessment of maternal and fetal status. Blood samples for hematology, clinical chemistries, biomarkers, coagulation, immunogenicity and AT activity levels will be drawn. Urine will be collected for baseline urinalysis, protein/creatinine ratio and biomarkers. Eligible subjects who meet inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive a continuous infusion of either ATryn or placebo.
Sampling for AT activity will be performed immediately prior to the first dose of study drug and at specified times thereafter.
Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation. The average extension of pregnancy with standard of care expectant management in this patient population is approximately 7 days. It is assumed that treatment with ATryn will provide an additional increase in gestational age of 5-7 days as compared to this standard of care. Total duration on study drug is therefore estimated to be approximately 7 to 14 days on average.
Post treatment assessments of the mother will be performed at hospital discharge and approximately 4-6 weeks after delivery of the neonate. Information on the neonates will be collected until they reach a post-menstrual age (PMA) of 36 weeks. If the neonate reaches 36 weeks PMA < 28 days following delivery, the final neonatal follow-up visit should be done at the 4-6 week post-delivery visit.
After the primary study completion and follow-up period, the neonate total number of days in the Neonatal Intensive Care Unit (NICU), days on a ventilator, days requiring supplemental oxygen (FiO2 ≥21%),the neonate hospital discharge date and whether the neonate is discharged from the hospital with a requirement for supplemental home oxygen therapy will be collected to help assess health care utilization. In addition, the date of death will be collected if the neonate expires before hospital discharge. These data will be considered supplemental to the primary study data set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Antithrombin (ATryn) | Active comparator | 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 |
| Normal Saline 0.9% | Placebo comparator | Other: Normal Saline 0.9%Placebo (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (28 listed)
- 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:
- 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:
- ≥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
Key exclusion criteria (25 listed)
- Criteria that would likely require immediate delivery of the fetus are exclusionary if present just prior to randomization:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human antithrombin (ATryn)Also: Recombinant human antithrombin (rhAT)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 | Biological | Recombinant Human Antithrombin (ATryn) |
| Normal Saline 0.9%Also: Normal SalinePlacebo Comparator: Normal Saline 0.9% | Other | Normal Saline 0.9% |
Primary outcome
Increase in Gestational Age in Days
Time frame: Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.
Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.
1 secondary outcome
Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)
Time frame: Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32780999Paidas MJ, Tita ATN, Macones GA, Saade GA, Ehrenkranz RA, Triche EW, Streisand JB, Lam GK, Magann EF, Lewis DF, Dombrowski MP, Werner EF, Branch DW, Habli MA, Grotegut CA, Silver RM, Longo SA, Amon E, Cleary KL, How HY, Novotny SR, Grobman WA, Whiteman VE, Wing DA, Scifres CM, Sibai BM. Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia. Am J Obstet Gynecol. 2020 Nov;223(5):739.e1-739.e13. doi: 10.1016/j.ajog.2020.08.004. Epub 2020 Aug 8.
- Derived from this study: PubMed 26886785Cotten CM. Adverse consequences of neonatal antibiotic exposure. Curr Opin Pediatr. 2016 Apr;28(2):141-9. doi: 10.1097/MOP.0000000000000338.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Paidas, MD principal investigator
Yale New Haven Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant human antithrombin (ATryn) and Normal Saline 0.9% in people with Preeclampsia, run by rEVO Biologics at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Gestational Age in Days (time frame: Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059135, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.