Healthy mature male and female neonates of gestational week = 37+0 with indication for hepatitis B prophylaxis due to a HBsAg positive mother. MedDRA version: 8.1 Level: LLT Classification code 10054130 Term: Hepatitis B immunisation
Conditions
Interventions
Product Code: BT088
Pharmaceutical Form: Solution for injection
Current Sponsor code: BT088
Other descriptive name: human Hepatitis B immunoglobulin
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the present study is the investigation on efficacy and safety regarding two types of administration (subcutaneous and intramuscular injection) of the new human hepatitis B immunoglobulin BT088 in neonates of HBsAg positive mothers to prevent perinatal transmission of hepatitis B. The primary study objective is to demonstrate efficacy which will be assessed by evaluation of the serum anti-HBs concentration prior to injection of BT088 and afterwards during an interval of 72 hours after birth. ;Secondary Objective: Secondary objectives regarding efficacy will be an assessment of the maternal infection status, i.e., in neonates who fail the target anti-HBs level of = 100 IU/L the maternal virus load will be determined. Furthermore an assessment of obstetrical conditions and treatments possibly related to a vertical HBV transmission and a surveillance of the efficacy of the active-passive immunisation will be performed. Secondary objectives in terms of safety are defined as observations on adverse events, physical examinations, vital signs, safety laboratory parameters and premature withdrawals. ;Primary end point(s): The primary study endpoint for assessment of efficacy, i.e. the efficacy response rate, is defined as the proportion of infants with an initial pre-dose anti-HBs concentration of < 10 IU/L and with at least one concentration of = 100 IU/L determined after BT088 injection during an interval of 72 hours post partum. This response limit of at least 100 IU/L is clinically well accepted and established for the procedure of hepatitis immunisation. | — |
Countries
Germany
Outcome results
None listed