EUCTR2014-000084-40-GB进行中（未招募）1 期
A randomized, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL).
ora Therapeutics, Inc.0 个研究点开始时间: 2014年3月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Pre-menopausal female 18-37 years of age at consent, trying to conceive
- •2.Documented history of unexplained recurrent pregnancy loss, defined as:
- •a. Spontaneous loss of three or more pregnancies prior to 20 completed weeks of gestation
- •b.At least two of the losses must have involved intrauterine clinical pregnancies prior to
- •20 completed weeks of gestation with normal or unknown fetal karyotype
- •3.Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
- •4.Body mass index (BMI) of 19-35 kg/m2 at consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Greater than 5 weeks of gestation (i.e. greater than 3 weeks since the ovulation date) when presenting for randomization. Ovulation date is defined as the day after the ovulation test is first positive.
- •2.Known karyotype abnormalities in either the participant or her current male partner
- •3.Uncorrected clinically significant intrauterine abnormalities present at the time of consent (as assessed by ultrasound, hysterosonography, hysterosalpingography, or hysteroscopy within 3 years prior to consent)
- •4.Abnormal vaginal bleeding of unknown cause
- •5.Current diagnosis of infertility in either the participant or her current male partner
- •6.Current or past diagnosis of the following:
- •a. Systemic autoimmune disease (e.g. systemic lupus erythematosus, Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis)
- •b. Antiphospholipid syndrome or disorder presence of lupus anticoagulant or anti-cardiolipin antibodies
- •c.Protein C or S deficiency
- •d. Other thrombophilia or evidence of thrombophilia (e.g. recurrent deep vein thrombosis, pulmonary embolism)
- •e.Hyperprolactinemia
- •f. High risk of cervical incompetence in the investigator’s opinion
- •g.High-grade cervical dysplasia with conization/surgery
- •7.Any uncontrolled clinically significant medical condition (e.g. asthma, type II diabetes, infection)
- •8.The following laboratory abnormalities at initial consent and within 3 months prior to randomization
- •a.Thrombocytopenia or thrombocytosis (platelet count < 75,000/µL or > 500,000/µL)
- •b.Neutropenia or neutrophilia (absolute neutrophil count < 1500/µL or > 10,000/µL)
- •c.Leukopenia or leukocytosis (white blood cell count < 3000/µL or > 15,000/µL)
- •d.Creatinine, hepatic transaminases, lactate dehydrogenase (LDH), alkaline phosphatase, or uric acid = 1.5x upper limit of normal (ULN)
- •9.Use of lithium within 1 month prior to consent
- •10.Known hypersensitivity to any rhG-CSF drug product, any of its components, or any E. coli-derived proteins
- •11.History of any of the following conditions:
- •a.Human immunodeficiency virus (HIV) infection
- •b.Malignancy within the past 5 years other than treated basal cell carcinoma or squamous cell carcinoma of the skin
- •c.Splenomegaly or splenic rupture
- •d.Adult respiratory distress syndrome (ARDS), acute lung injury (ALI), or pulmonary edema
- •e.Sickle cell anemia
- •f.Acute myocardial infarction, stroke, or revascularization (coronary or cerebral)
- •12.Previous rhG-CSF therapy for any indication
- •13.In the investigator’s opinion, any contraindication to the use of an investigational drug
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