Treatments and/or Procedures

Study Criteria

Inclusion Criteria:

  1. Patients who gave written consent to participate in the clinical trial by their own
     free will.

  2. Patients aged 20 years or older at the time of obtaining informed consent

  3. Patients with early-onset PE* 24 weeks 0 days to 31 weeks 6 days of gestation at the
     time of enrollment

     *: Determine the definition of gestational age based on the "Guidelines for Obstetrics
     and Gynecology, Obstetrics, 2017"

  4. Patients diagnosed with severe PE*

     *: Follow the diagnostic criteria of the Japan Society for the Study of Hypertension
     in Pregnancy

  5. Patients with AT activity of 100% or less in the preliminary examination

Exclusion Criteria:

  1. Patients who are judged to require immediate delivery*

     *"Best Practice Guide 2015 for Care and Treatment of Hypertension in Pregnancy"
     Requirements for Considering Pregnancy Termination Regardless of Pregnancy Weeks in
     Pregnancy-induced Hypertension Syndrome Cases will be consulted for judgment.

  2. Patients with right hypochondralgia or epigastralgia

  3. Patients with HELLP syndromes

  4. Patients with pulmonary edema

  5. Patients with severe pleural effusion, severe ascites, or serous retinal detachment

  6. Patients with central nervous system disorders (eclampsia, stroke) or visual disorders
     (cortical blindness)

  7. Patients with severe headache or urge eclampsia

  8. Patients with abruptio placentae

  9. Suspected patients with 8 or more obstetric DIC scores

 10. Patients with a definitive diagnosis of congenital AT deficiency

 11. Patients with diseases or symptoms other than the primary disease requiring immediate
     delivery

 12. Patients on ongoing treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, e.g.,
     aspirin) or who require NSAIDs use during the course of the study.

 13. Patients who have received the following drugs within 72 hours before administration
     of the investigational product, etc., or who require administration of the following
     drugs during the study period (from the start of administration of the investigational
     product, etc., until the date of termination of pregnancy); heparin,
     low-molecular-weight heparin (e.g., enoxaparin or dalteparin), fondaparinux,
     antiplatelet drugs (e.g., clopidogrel, prasugrel, aspirin), direct thrombin inhibitors
     (e.g., dabigatran), or anticoagulants (e.g., AT preparations).

 14. Patients with a current or past history of serious drug allergy

 15. Patients with a history or complication of drug dependence or alcoholism

 16. Patients with hypersensitivity to AT preparations

 17. Patients who are pregnant with a fetus with a chromosomal abnormality or a fetus
     suspected of having a serious malformation syndrome

 18. Patients with multiple pregnancies

 19. Patients with a history or complication of antiphospholipid antibody syndrome

 20. Patients with diabetes complicated pregnancy, obvious diabetes mellitus, or insulin
     use

 21. Patients with uncontrollable or significant complications, including the following

       -  Clinically significant cardiovascular diseases, etc. (New York Heart Association
          cardiac function classifications Class III or higher)

       -  Serious hepatic disease

       -  Serious renal disease

       -  Pneumonia, interstitial lung disease or other severe respiratory disease

       -  Blood disorders such as idiopathic thrombocytopenic purpura

       -  Psycho-central nervous system disorders that may affect informed consent

       -  Endocrine disorders such as hyperthyroidism

       -  Autoimmune diseases such as systemic lupus erythematosus

 22. Patients with active malignancy or patients with a history of onset or treatment of
     malignancy within 5 years before pregnancy (excluding excised or surgically cured
     basal cell carcinoma of the skin, squamous cell carcinoma of the skin or ductal
     carcinoma of the breast)

 23. Patients with active infections (e.g., toxoplasma infection, genital chlamydia,
     genital herpes, cytomegalovirus infection)

 24. Patients with a positive history for HIV antibody. Patients with a positive history
     for HBs antigen and HCV antibody and with active infection presenting with hepatitis
     symptoms.

 25. Patients with any of the following laboratory abnormalities in preliminary
     examinations; Patients with AST or ALT 2 times the upper limit of the reference level
     of the trial site; Cr >=1.1 mg/dL

 26. Patients who have participated in a clinical trial or equivalent study of a drug or
     medical device within 4 months before pregnancy (within 6 months for biologics) and
     have received the investigational drug or used an unapproved medical device

 27. Other patients whom the principal investigator or the subinvestigator judges to be
     unfavorable for participation in the clinical trial