KW-3357 Study in Patients With Early Onset Severe Preeclampsia
NCT ID: NCT04182373
Last Updated: 2023-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
181 participants
INTERVENTIONAL
2019-11-19
2023-06-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia
NCT06157580
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
NCT05937841
Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
NCT01566630
Atenativ Effect on Uterine Blood Flow and Preeclampsia
NCT02278575
Losartan for Improved Vascular Endothelial Function After Preeclampsia
NCT04632589
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
KW-3357
72 IU/kg
Antithrombin gamma
Intravenous infusion, once a day, 7 days
placebo
physiological saline
Intravenous infusion, once a day, 7 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Antithrombin gamma
Intravenous infusion, once a day, 7 days
physiological saline
Intravenous infusion, once a day, 7 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients aged 18 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, 2020""
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
\*""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 ordalteparin), 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 or obvious diabetes mellitus
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, and excluding cervical intraepithelial neoplasia regardless of excised or surgically cured or not)
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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Japan Blood Products Organization
INDUSTRY
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Toyota Memorial Hospital
Toyota, Aichi-ken, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
National Hospital Organization Kokura Medical Center
Kitakyushu, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
Kurume, Fukuoka, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, Japan
Obihiro Kosei General Hospital
Obihiro, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Iwate Medical University Hospital
Hizume, Iwate, Japan
National Hospital Organization Shikoku Medical Center for Children and Adults
Zentsujichó, Kagawa-ken, 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-ken, Japan
Sendai Red Cross Hospital
Sendai, Miyagi, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Okinawa prefectural Chubu Hospital
Uruma, Okinawa, Japan
Osaka Metropolitan University Hospital
Abeno-ku, Osaka, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Osaka Women's and Children's Hospital
Izumi, Osaka, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Dokkyo Medical University Hospital
Mibu, Tochigi, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
The University of Tokyo Hospital
Bunkyo, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
Fuchū, Tokyo, Japan
Aiiku Hospital
Minato, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
National Center for Child Health and Development
Setagaya City, Tokyo, Japan
Japanese Red Cross Medical Center
Shibuya City, Tokyo, Japan
Showa University Hospital
Shinagawa, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida City, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Aomori Prefectural Central Hospital
Aomori, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Kagoshima City Hospital
Kagoshima, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Faculty of Medicine, University of Miyazaki Hospital
Miyazaki, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Nara Prefecture General Medical Center
Nara, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka City General Hospital
Osaka, , Japan
Oita Prefectural Hospital
Ōita, , Japan
Toyama University Hospital
Toyama, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saito S, Takagi K, Moriya J, Kobayashi T, Kanayama N, Sameshima H, Morikawa M, Sago H, Adachi T, Ohkuchi A, Takeda S, Masuyama H, Seki H. A randomized phase 3 trial evaluating antithrombin gamma treatment in Japanese patients with early-onset severe preeclampsia (KOUNO-TORI study): Study protocol. Contemp Clin Trials. 2021 Aug;107:106490. doi: 10.1016/j.cct.2021.106490. Epub 2021 Jun 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3357-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.