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Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia (PRESERVE-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rEVO Biologics
ClinicalTrials.gov Identifier:
NCT02059135
First received: February 6, 2014
Last updated: July 11, 2017
Last verified: July 2017
Results First Received: June 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Preeclampsia
Interventions: Biological: Recombinant human antithrombin (ATryn)
Other: Normal Saline 0.9%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

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 (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.

Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%


Participant Flow for 2 periods

Period 1:   Maternal Follow-up (ITT Population)
    Recombinant Human Antithrombin (ATryn)   Normal Saline 0.9%
STARTED   62   58 
COMPLETED   59   51 
NOT COMPLETED   3   7 
Withdrawal by Subject                3                2 
Lost to Follow-up                0                3 
declined to see site staff                0                1 
didn't return to site (f/u elsewhere)                0                1 

Period 2:   Neonatal Follow-up (Safety Population)
    Recombinant Human Antithrombin (ATryn)   Normal Saline 0.9%
STARTED   60   54 
COMPLETED   56   50 
NOT COMPLETED   4   4 
Lost to Follow-up                1                0 
Death                3                2 
delivered at another hospital                0                1 
Withdrawal by Subject                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population

Reporting Groups
  Description
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

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 (Normal Saline 0.9%, matched for volume of active treatment) consisting of a loading dose over 15 minutes followed by continuous infusion.

Normal Saline 0.9%: Placebo Comparator: Normal Saline 0.9%

Total Total of all reporting groups

Baseline Measures
   Recombinant Human Antithrombin (ATryn)   Normal Saline 0.9%   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   58   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.0  (6.1)   29.3  (6.7)   29.2  (6.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      62 100.0%      58 100.0%      120 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      6   9.7%      10  17.2%      16  13.3% 
Not Hispanic or Latino      56  90.3%      48  82.8%      104  86.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   3.2%      1   1.7%      3   2.5% 
Native Hawaiian or Other Pacific Islander      1   1.6%      0   0.0%      1   0.8% 
Black or African American      27  43.5%      27  46.6%      54  45.0% 
White      29  46.8%      30  51.7%      59  49.2% 
More than one race      1   1.6%      0   0.0%      1   0.8% 
Unknown or Not Reported      2   3.2%      0   0.0%      2   1.7% 
Region of Enrollment 
[Units: Participants]
     
United States   62   58   120 
Gestational Age at Randomization 
[Units: Weeks]
Mean (Standard Deviation)
 27.18  (1.96)   27.34  (2.06)   27.25  (2.00) 
Type of Preeclampsia 
[Units: Participants]
Count of Participants
     
Preeclampsia      39  62.9%      32  55.2%      71  59.2% 
Superimposed Preeclampsia      23  37.1%      26  44.8%      49  40.8% 
Parity (number of previous live births) 
[Units: Participants]
Count of Participants
     
    37  59.7%      16  27.6%      53  44.2% 
    14  22.6%      20  34.5%      34  28.3% 
    6   9.7%      11  19.0%      17  14.2% 
    4   6.5%      4   6.9%      8   6.7% 
    1   1.6%      6  10.3%      7   5.8% 
    0   0.0%      1   1.7%      1   0.8% 
>5      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   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) ]

3.  Other Pre-specified:   Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality   [ Time Frame: 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). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Laura Massey, Sr. Clinical Project Manager
Organization: LFB USA
phone: 508-370-5157
e-mail: laura.massey@lfb-usa.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: rEVO Biologics
ClinicalTrials.gov Identifier: NCT02059135     History of Changes
Other Study ID Numbers: RB AT PPE 01-13
Study First Received: February 6, 2014
Results First Received: June 13, 2017
Last Updated: July 11, 2017