EUCTR2007-004692-19-IT进行中（未招募）1 期
Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus during pregnancy. A randomised, open, controlled, prospective, multicentre and multinational study investigating efficacy and safety of Cytotect FH, nanometer filtered (BT094). - Biotest 963
适应症
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
- 25,000
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
- Female
入选标准
- •1. OREGNANT WOMAN, PREGNANCY AFTER IN VITRO FERTILISATION PERMITTED 2. CMV-SPECIFIC IgG seronegative pregnant women at study entry 3. 18 to 45 years of age 4. consent to carrying out a histopatological analysis of foetal brain, liver and pleen biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed serconversion during pregnancy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100000
- •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
- •1. women with multigravidity 2. women who are planning a home birth 3. known immunodeficiency or immunosuppression 4. known hepatitis Bor C infections 5. known intolerance to proteins of human origin 6.known intolerance to immunoglobulins or comparable substances 7. known or suspected deficiency of immunoglobulin A 8. known HIV infection 9. Known hypersensivity and/or idiosyncrasy to any of the test compounds or excipients amployed.
研究者
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