EUCTR2015-005751-27-ES进行中（未招募）1 期
A Multi-Center, Open-Label, Randomized, Single-Dose, Controlled Trial of Intravenously Administered XOMA 213 in Suppression of Lactation after Delivery in Postpartum Women
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Subjects may be included in the study if ALL of the following criteria are met:
- •1.Provide written informed consent before any study specific procedures are performed
- •2.Female, aged 18 to 45 years, pregnant with a gestational age of at least 36 weeks, and expected to deliver within 21 days of study Screening
- •3.Wishing to suppress lactation immediately after delivery
- •4.Willing to be hospitalized for 3 consecutive days immediately after delivery
- •5.For female subjects with reproductive potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile), a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for at least 3 months after administration of study drug. For women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended.
- •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 35
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from the study if ANY of the following criteria are met:
- •1.History of mastitis
- •2.History of pituitary disease
- •3.History of intrauterine fetal death, bleeding disorder, pre-eclampsia, liver or kidney impairment, or any severe complication associated with the current or prior pregnancies
- •4.History of pregnancy-related hypertension, (eg, preeclampsia, eclampsia, or post partum hypertension), which are contraindications to cabergoline
- •5.Major general surgery (including C-section) within 3 months before study entry or anticipated during the study period
- •6.Seropositivity for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
- •7.Treatment within 30 days before study entry or concurrent treatment during the study with any drug, other than study drug, that affects prolactin levels or lactation (eg, cabergoline, bromocriptine, other dopamine agonists, or antidepressants)
- •8.History of severe allergic or anaphylactic reaction to monoclonal antibodies
- •9.Any out-of-range laboratory value at Screening that has not been reviewed, approved, and documented as not clinically significant by the Investigator
- •10.Presence of clinically significant cardiac disease or failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension
- •11.History of malignancy within 3 years before study entry other than carcinoma in situ of the cervix or adequately treated nonmetastatic squamous or basal cell carcinoma of the skin
- •12.Known allergy or sensitivity to XOMA 213 or any component of the study drug or known contraindications to treatment with cabergoline
- •13.Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug, whichever is longer, before Day 1. Participation in registries and purely diagnostic studies is allowed.
- •14.Any condition that, in the opinion of the investigator, would jeopardize the subject’s safety after exposure to the study drug. Any condition (eg, psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
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