KW-3357 Study in Patients With Early Onset Severe Preeclampsia
- Conditions
- Preeclampsia
- Interventions
- Drug: physiological saline
- Registration Number
- NCT04182373
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 181
-
Patients who gave written consent to participate in the clinical trial by their own free will.
-
Patients aged 18 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, 2020""
-
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
-
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 detachment
-
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 study.
-
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 ordalteparin), 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 syndrome
-
Patients with diabetes complicated pregnancy or obvious diabetes mellitus
-
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
-
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, and excluding cervical intraepithelial neoplasia regardless of excised or surgically cured or not)
-
Patients with active infections (e.g., toxoplasma infection, genital chlamydia, genital herpes, cytomegalovirus infection)
-
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.
-
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
-
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
-
Other patients whom the principal investigator or the subinvestigator judges to be unfavorable for participation in the clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo physiological saline - KW-3357 Antithrombin gamma 72 IU/kg
- Primary Outcome Measures
Name Time Method Days of maintaining pregnancy Subjects will be observed until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until approximately 34 0/7 weeks of gestation.
- Secondary Outcome Measures
Name Time Method Presence or absence of achievement of 34 weeks of gestation 28 days before the end of study Presence or absence of achievement of 28 weeks of gestation in subjects enrolled in the period of less than 28 weeks of gestation 28 days before the end of study Change in AT activity From baseline to Day 8 at all time points and 3 days after termination of pregnancy Change in PLT concentration From baseline to Day 8 at all time points and 3 days after termination of pregnancy Change on D-dimer concentration From baseline to Day 8 at all time points Change in FDP concentration From baseline to Day 8 at all time points Sitting systolic blood pressure and sitting diastolic blood pressure From baseline to Day 8 at each time point, 3 days after termination of pregnancy, and 28 days after termination of pregnancy Presence or absence of achievement of 32 weeks of gestation 28 days before the end of study Proteinuria/creatinine ratio From baseline to Day 8 at each time point, 3 days after termination of pregnancy, and 28 days after termination of pregnancy Amount of blood lost during delivery 28 days before the end of study Biophysical Profile Score From baseline to Day 8 at each time point Minimum is 0, max is 10. Higher score means better condition.
Fetal growth rate 28 days before the end of study Apgar score At 1 minute and 5 minutes after birth Minimum is 0, max is 10. Higher score means better condition.
Presence or absence of neonatal asphyxia At 1 minute and 5 minutes after birth Birth weight 28 days before the end of study Neonatal growth 28 days before the end of study Fetal growth is classified into small for gestational age (SGA), appropriate for gestational age (AGA), and large for gestational age (LGA).
Head and chest circumferences at birth 28 days before the end of study Short-term prognosis of neonates (incidence of bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukolame, retinopathy of prematurity, sepsis, necrotizing enteritis, death, etc) 28 days after termination of pregnancy The number of neonates who was hospitalized in the NICU 28 days after termination of pregnancy The number of days in the NICU 28 days after termination of pregnancy The number of neonates with respiratory management at the time of admission to the NICU 28 days after termination of pregnancy The number of days of respiratory management at the time of admission to the NICU 28 days after termination of pregnancy
Trial Locations
- Locations (63)
National Center for Child Health and Development
🇯🇵Setagaya, Tokyo, Japan
Aiiku Hospital
🇯🇵Minato, Tokyo, Japan
Okinawa prefectural Chubu Hospital
🇯🇵Uruma, Okinawa, Japan
National Hospital Organization Kokura Medical Center
🇯🇵Kitakyushu, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Kagoshima City Hospital
🇯🇵Kagoshima, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Aichi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
🇯🇵Nagoya, Aichi, Japan
Toyota Memorial Hospital
🇯🇵Toyota, Aichi, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Chiba, Japan
Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Tokyo Women's Medical University Yachiyo Medical Center
🇯🇵Yachiyo, Chiba, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Obihiro Kosei General Hospital
🇯🇵Obihiro, Hokkaido, Japan
Hakodate Central General Hospital
🇯🇵Hakodate, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Sapporo City General Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Japanese Red Cross Society Himeji Hospital
🇯🇵Himeji, Hyogo, Japan
Iwate Medical University Hospital
🇯🇵Shiwa, Iwate, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
National Hospital Organization Shikoku Medical Center for Children and Adults
🇯🇵Zentsuji, Kagawa, Japan
St. Marianna University School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
The Kitasato Institute Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Sendai Red Cross Hospital
🇯🇵Sendai, Miyagi, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Omura, Nagasaki, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
Osaka Metropolitan University Hospital
🇯🇵Abeno-ku, Osaka, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Osaka, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Osaka Women's and Children's Hospital
🇯🇵Izumi, Osaka, Japan
Saitama Medical Center
🇯🇵Kawagoe, Saitama, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
National Cerebral and Cardiovascular Center
🇯🇵Suita, Osaka, Japan
Hamamatsu Medical Center
🇯🇵Hamamatsu, Shizuoka, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Juntendo University Shizuoka Hospital
🇯🇵Izunokuni, Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Dokkyo Medical University Hospital
🇯🇵Mibu, Tochigi, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
🇯🇵Fuchu, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida, Tokyo, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu, Yamanashi, Japan
Aomori Prefectural Central Hospital
🇯🇵Aomori, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Faculty of Medicine, University of Miyazaki Hospital
🇯🇵Miyazaki, Japan
Oita Prefectural Hospital
🇯🇵Oita, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Nara Prefecture General Medical Center
🇯🇵Nara, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Osaka City General Hospital
🇯🇵Osaka, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Japanese Red Cross Medical Center
🇯🇵Shibuya, Tokyo, Japan
Showa University Hospital
🇯🇵Shinagawa, Tokyo, Japan