jRCT2080224912已完成3 期
A Phase 3, randomized, placebo-controlled, double blind study of KW-3357 in patients with early onset severe preeclampsia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Randomized, Placebo-controlled, Double-blind Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Female
入选标准
- •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 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 test
排除标准
- •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 Case 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 gestation); 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 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
- •Severe 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
结局指标
主要结局
-
confirmatory Days of maintaining pregnancy (Days from the start date of investigational drug to the date of pregnancy termination)
次要结局
- Assessment of gestational age
- Blood coagulation factors(baseline to Day 8 at all time points and 3 days after termination of pregnancy)
- Sitting systolic blood pressure and sitting diastolic blood pressure(baseline to Day 8 at each examination time point, 3 days after termination of pregnancy, and 28 days after termination of pregnancy)
- Proteinuria/creatinine ratio(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
- Biophysical Profile Score(baseline to Day 8 at each time point)
- Apgar score(1 minute and 5 minutes after birth)
- Fetal growth rate(during the period of administration of the investigational product)
- NICU hospitalization(28 days after termination of pregnancy)
- Biomarkers(baseline to Day 8)
- Pulsatility index and findings of the umbilical artery and middle cerebral artery(baseline to Day 8)
- Reason for termination of pregnancy
- Prolongation days of pregnancy
- Birth weight and neonatal growth
- Head and chest circumferences at birth(at birth)
- Respiratory management(28 days after termination of pregnancy)
- Short-term prognosis of neonates(28 days after termination of pregnancy)
- Labor findings
- Umbilical arterial blood gas(at termination of pregnancy)
- HELLP syndromes(during the course of the clinical trial)
研究者
研究点 (1)
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