Trial · NCT02059135
Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
NCT02059135, Phase 3, Completed, rEVO Biologics; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia. Trials, record NCT02059135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02059135
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
- NCT number
- NCT02059135
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- rEVO Biologics
- Conditions
- Preeclampsia
- Interventions
- Recombinant human antithrombin (ATryn), Normal Saline 0.9%
- First posted
- 2014-02-11
- Last updated
- 2017-08-09
- Results first posted
- 2017-08-09
- Limitations and caveats
Note: 6 subjects (2 in the Recombinant Human Antithrombin (ATryn) group and 4 in the placebo group) were randomized but received no treatment. These subjects are included in the ITT population but not the maternal safety population.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Increase in Gestational Age in Days | 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. |
| Secondary | Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4) | 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) | 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 1. One event, no mortality 2. Two events, no mortality 3. Three or more events, no mortality 4. Death |
| Other | Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery). | Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs \<28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity \[BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell's stage ≥ 2)\]. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Increase in Gestational Age in Days | 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. | ITT | days | MEDIAN |
| SECONDARY | Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4) | 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) | ITT | scores on a scale of 0 to 4 | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery). | ITT | participants | NUMBER |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Increase in Gestational Age in Days | Recombinant Human Antithrombin (ATryn) | 5.0 | Full Range 0 to 75 | days | |
| Increase in Gestational Age in Days | Normal Saline 0.9% | 6.0 | Full Range 0 to 85 | days | |
| Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4) | Recombinant Human Antithrombin (ATryn) | 0.7 | Standard Deviation 1.0 | scores on a scale of 0 to 4 | |
| Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4) | Normal Saline 0.9% | 0.6 | Standard Deviation 0.9 | scores on a scale of 0 to 4 | |
| Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Recombinant Human Antithrombin (ATryn) | Maternal Death | 0 | participants | |
| Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Normal Saline 0.9% | Maternal Death | 0 | participants | |
| Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Recombinant Human Antithrombin (ATryn) | Maternal Eclamptic Seizure | 0 | participants | |
| Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Normal Saline 0.9% | Maternal Eclamptic Seizure | 1 | participants | |
| Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Recombinant Human Antithrombin (ATryn) | Maternal Myocardial Infarction | 0 | participants | |
| Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality | Normal Saline 0.9% | Maternal Myocardial Infarction | 0 | participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Maternal Follow-up (ITT Population) | STARTED | Recombinant Human Antithrombin (ATryn) | 62 | |
| Maternal Follow-up (ITT Population) | STARTED | Normal Saline 0.9% | 58 | |
| Maternal Follow-up (ITT Population) | COMPLETED | Recombinant Human Antithrombin (ATryn) | 59 | |
| Maternal Follow-up (ITT Population) | COMPLETED | Normal Saline 0.9% | 51 | |
| Maternal Follow-up (ITT Population) | NOT COMPLETED | Recombinant Human Antithrombin (ATryn) | 3 | |
| Maternal Follow-up (ITT Population) | NOT COMPLETED | Normal Saline 0.9% | 7 | |
| Neonatal Follow-up (Safety Population) | STARTED | Recombinant Human Antithrombin (ATryn) | 60 | |
| Neonatal Follow-up (Safety Population) | STARTED | Normal Saline 0.9% | 54 | |
| Neonatal Follow-up (Safety Population) | COMPLETED | Recombinant Human Antithrombin (ATryn) | 56 | |
| Neonatal Follow-up (Safety Population) | COMPLETED | Normal Saline 0.9% | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events260
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Maternal/Fetal Safety Population: ATryn | 32 | 60 | |
| other | Hypertension | Vascular disorders | Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | 25 | 54 | |
| other | Hypertension | Vascular disorders | Neonatal Safety Population: ATryn | 0 | 0 | |
| other | Hypertension | Vascular disorders | Neonatal Safety Population: Placebo | 0 | 0 | |
| other | Headache | Nervous system disorders | Maternal/Fetal Safety Population: ATryn | 24 | 60 | |
| other | Headache | Nervous system disorders | Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | 19 | 54 | |
| other | Headache | Nervous system disorders | Neonatal Safety Population: ATryn | 0 | 0 | |
| other | Headache | Nervous system disorders | Neonatal Safety Population: Placebo | 0 | 0 | |
| other | Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Maternal/Fetal Safety Population: ATryn | 20 | 60 | |
| other | Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | 12 | 54 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maternal/Fetal Safety Population: ATryn | 0 | 60 |
| Total, all-cause mortality | Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | 0 | 54 |
| Total, all-cause mortality | Neonatal Safety Population: ATryn | 3 | 60 |
| Total, all-cause mortality | Neonatal Safety Population: Placebo | 2 | 54 |
| Total, other adverse events | Maternal/Fetal Safety Population: ATryn | 60 | 60 |
| Total, other adverse events | Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | 53 | 54 |
| Total, other adverse events | Neonatal Safety Population: ATryn | 0 | 0 |
| Total, other adverse events | Neonatal Safety Population: Placebo | 0 | 0 |
| Total, serious adverse events | Maternal/Fetal Safety Population: ATryn | 10 | 60 |
| Total, serious adverse events | Maternal/Fetal Safety Population: Placebo (Normal Saline 0.9%) | 11 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02059135
GET https://conductscience.org/api/trials/v1/NCT02059135/results?page=2