EUCTR2007-004692-19-BE进行中（未招募）1 期
Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094) - Prevention of congenital CMV infection in infants of mothers with primary CMV infection during preg.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 16,000
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
- All
入选标准
- •- Pregnant women, pregnancy after in-vitro fertilisation permitted
- •- CMV-specific IgG seronegative pregnant women at screening
- •- 18 to 45 years of age
- •- Consent to carrying out a histopathological analysis of foetal brain, liver and kidney biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed seroconversion during pregnancy
- •-Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 98
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- women with current multiple pregnancy
- •- women who are planning a home birth
- •- known immunodeficiency (e.g. congenital agammaglobulinaemia or hypo-gamma-globulinaemia, common variable immunodeficiency, severe combined immuno-deficiencies, Wiskott Aldrich syndrome) or immunosuppression (e.g. renal transplanted patients)
- •- known hepatitis B or C infections
- •- known intolerance to proteins of human origin
- •- known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
- •- Known hypersensitivity to homologous immunoglobulins, especially very rare cases of IgA deficiency, when the patient has antibodies against IgA
- •- known HIV infection
- •- Known pre-existing risk factors for thrombotic events (e.g. history of vascular disease or thrombotic episodes, women with acquired or inherited thrombophilic disorders, severely hypovolemic women or women with diseases which increase blood viscosity)
- •- Known renal insufficiency
- •- Known hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed
- •- Participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study during the same pregnancy
- •- Inability or lack of motivation to participate in the study
- •- Pregnant women who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
- •- Not willing or able to provide written informed consent to participation in the study after being informed by the investigator about the aim, course and possible risks of the study
- •- Not willing to give consent to transmission of personal pseudonymised” data to the competent authorities
- •- Women who are dependant on study site staff, on Biotest AG or its authorised representatives
研究者
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