KW-3357 Study in Patients With Early Onset Severe Preeclampsia

  • End date
    Jun 22, 2022
  • participants needed
  • sponsor
    Kyowa Kirin Co., Ltd.
Updated on 22 October 2020
Kyowa Kirin Co., Ltd.
Primary Contact
Dokkyo Medical University Hospital (9.8 mi away) Contact
+60 other location
severe pre-eclampsia


The purpose of this study is to evaluate the efficacy of intravenous KW-3357 in patients with early-onset severe preeclampsia by comparing the prolongation days of pregnancy with that of placebo.

Treatment physiological saline, Antithrombin gamma
Clinical Study IdentifierNCT04182373
SponsorKyowa Kirin Co., Ltd.
Last Modified on22 October 2020

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Inclusion Criteria

Is your age greater than or equal to 20 yrs?
Are you female?
Do you have any of these conditions: Pre-Eclampsia or Preeclampsia?
Patients who gave written consent to participate in the clinical trial by their own free will
Patients aged 20 years or older at the time of obtaining informed consent
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
\. Patients diagnosed with severe PE
Follow the diagnostic criteria of the Japan Society for the Study of Hypertension in Pregnancy
\. Patients with AT activity of 100% or less in the preliminary examination

Exclusion Criteria

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
\. Patients with right hypochondralgia or epigastralgia
\. Patients with HELLP syndromes
\. Patients with pulmonary edema
\. Patients with severe pleural effusion, severe ascites, or serous retinal
\. Patients with central nervous system disorders (eclampsia, stroke) or
visual disorders (cortical blindness)
\. Patients with severe headache or urge eclampsia
\. Patients with abruptio placentae
\. Suspected patients with 8 or more obstetric DIC scores
\. Patients with a definitive diagnosis of congenital AT deficiency
\. Patients with diseases or symptoms other than the primary disease
requiring immediate delivery
\. Patients on ongoing treatment with nonsteroidal anti-inflammatory drugs
(NSAIDs, e.g., aspirin) or who require NSAIDs use during the course of the
\. 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)
\. Patients with a current or past history of serious drug allergy
\. Patients with a history or complication of drug dependence or alcoholism
\. Patients with hypersensitivity to AT preparations
\. Patients who are pregnant with a fetus with a chromosomal abnormality or
a fetus suspected of having a serious malformation syndrome
\. Patients with multiple pregnancies
\. Patients with a history or complication of antiphospholipid antibody
\. Patients with diabetes complicated pregnancy, obvious diabetes mellitus
or insulin use
\. Patients with uncontrollable or significant complications, including the
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
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