EUCTR2006-000110-21-DE进行中（未招募）不适用
An open, randomised parallel study investigating efficacy and safety of the human hepatitis B immunoglobulin BT088 after subcutaneous or intramuscular application for perinatal prophylaxis in infants born to HbsAg positive women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 31
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
- •Male or female neonate of gestational week = 37+0
- •Body weight = 2500 g
- •Apgar score, 5 minutes value > 7
- •Confirmation of HBsAg positive mother
- •Available written informed consent of parents or legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Infant is too small for gestational age (i.e., < 2500 g)
- •Outpatient birth
- •Known or suspected intrauterine infection
- •(e.g. rubella, parvovirus B19, cytomegalovirus)
- •Complicated neonatal infection
- •Congenital malformation requiring major surgery
- •Known or suspected chromosomal aberration
- •Known or suspected intolerance to immunoglobulins
- •or comparable substances (e.g., vaccination reaction)
- •Known or suspected intolerance to proteins of human origin
- •Known deficiency of immunoglobulin A in the family
- •(parents and siblings of the neonate)
- •Suspected severe thrombocytopenia or any coagulation disorder
- •leading to contraindications for intramuscular injections
- •Any further condition which according to the investigator results
- •in an undue risk for the infant during participation in this study
- •Inability of the parents or the legal guardian to understand the
- •study-specific information and measures
- •Inability or lacking motivation of the parents or the legal guardian
- •to have the child participate in the study
- •Parents or legal guardian are employees of any involved study
- •investigator or any involved institution including study sponsor
- •Parallel participation of the infant in another clinical trial or
- •treatment with another investigational product during this study
- •Infants with an indwelling cannula for intravenous access
研究者
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