KW-3357 Study in Patients With Early Onset Severe Preeclampsia
A Phase 3, Randomized, Placebo-controlled, Double Blind Study of KW-3357 in Patients With Early Onset Severe Preeclampsia
1 other identifier
interventional
181
1 country
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2019
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedStudy Start
First participant enrolled
November 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2023
CompletedNovember 15, 2023
November 1, 2023
3.5 years
October 10, 2019
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
Presence or absence of achievement of 32 weeks of gestation
28 days before the end of study
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
- +17 more secondary outcomes
Other Outcomes (17)
Change in TNF-alpha at the time of examination
From baseline to Day 8
Change in interleukin (IL)-6 at the time of examination
From baseline to Day 8
Change in IL-10 at the time of examination
From baseline to Day 8
- +14 more other outcomes
Study Arms (2)
KW-3357
EXPERIMENTAL72 IU/kg
placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin Co., Ltd.lead
- Japan Blood Products Organizationcollaborator
Study Sites (63)
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
Related Publications (1)
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.
PMID: 34174463BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
December 2, 2019
Study Start
November 19, 2019
Primary Completion
May 17, 2023
Study Completion
June 16, 2023
Last Updated
November 15, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.