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Summary
EudraCT Number:2006-000110-21
Sponsor's Protocol Code Number:BT959
National Competent Authority:Germany - PEI
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2006-07-31
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - PEI
A.2EudraCT number2006-000110-21
A.3Full title of the trial
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
A.4.1Sponsor's protocol code numberBT959
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorBiotest AG
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.2Product code BT088
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeBT088
D.3.9.3Other descriptive namehuman Hepatitis B immunoglobulin
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product Yes
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.2Product code BT088
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeBT088
D.3.9.3Other descriptive namehuman Hepatitis B immunoglobulin
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product Yes
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Healthy mature male and female neonates of gestational week ≥ 37+0 with indication for hepatitis B prophylaxis due to a HBsAg positive mother.
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10054130
E.1.2Term Hepatitis B immunisation
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
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.
E.2.2Secondary objectives of the trial
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.
E.2.3Trial contains a sub-study No
E.3Principal 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
E.4Principal 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
E.5 End points
E.5.1Primary 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.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
parallel group/s.c./i.m. with respect to the response limit of 100 U/L for hepatitis B immunisation
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned3
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA5
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years3
E.8.9.2In all countries concerned by the trial months6
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) Yes
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
mature neonates, written informed consent by partents/legal guardian
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state62
F.4.2 For a multinational trial
F.4.2.1In the EEA 31
F.4.2.2In the whole clinical trial 31
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Passive immunisation is single administration within 12 hours after birth. Active HBV immunisation is to be performed according to vaccination guidelines with registered vaccines. Regarding efficacy surveillance, hepatitis B marker will be evaluated in Germany about 4-8 weeks after the third active immunisation. (Germany/Hungary 7 - 15 month after birth)
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-11-15
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-11-21
P. End of Trial
P.End of Trial StatusCompleted

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