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Efficacy and Safety evaluation of Kedrion Human Hepatitis B Immunoglobulin for intramuscular use in the prevention of hepatitis B in the newborns of Hepatitis B Virus carrier-mothers: multi-centre, open-label, phase IV clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021473-36-IT

Enrollment

184

Registered

2012-03-08

Start date

2011-11-22

Completion date

Unknown

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborns of hepatitis B virus carrier mothers MedDRA version: 14.1 Level: LLT Classification code 10019619 Term: Hep B System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: IMMUNOHBS Pharmaceutical Form: Solution for injection INN or Proposed INN: HUMAN HEPATITIS B IMMUNOGLOBULIN CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newborn of hepatitis B virus carrier-mothers. 2. Newborn is receiving Hepatitis B virus vaccination according to the scheme 0-1-6 months. 3. Parents/Legal Guardians should have been informed of the nature of the study, agreed to its provision, signed and dated the Informed Consent and the Authorization for Data Handling form approved by the EC. Are the trial subjects under 18? yes Number of subjects for this age range: 184 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: 1. Newborn from mother treated during pregnancy with Human Hepatitis B Immunoglobulins. 2. Informed Consent and/or the Authorization for Data Handling approved by the EC not signed by Parents/Legal Guardians.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy evaluation: To evaluate if treatment with UMAN BIG/IMMUNOHBs (IMP) at the posology foreseen by the SmPC (30-100 IU/Kg) is able to prevent hepatitis B in the newborns of hepatitis B virus carrier-mothers. Safety evaluation: To evaluate the safety and tolerability of the IMP during the study period.;Secondary Objective: See above;Primary end point(s): Absence of Hepatitis B infection in the newborns (HBsAg negative status).;Timepoint(s) of evaluation of this end point: Maximum 9 months/patient	—

Measure

Time frame

Main Objective: Efficacy evaluation: To evaluate if treatment with UMAN BIG/IMMUNOHBs (IMP) at the posology foreseen by the SmPC (30-100 IU/Kg) is able to prevent hepatitis B in the newborns of hepatitis B virus carrier-mothers. Safety evaluation: To evaluate the safety and tolerability of the IMP during the study period.;Secondary Objective: See above;Primary end point(s): Absence of Hepatitis B infection in the newborns (HBsAg negative status).;Timepoint(s) of evaluation of this end point: Maximum 9 months/patient

—

Secondary

Measure	Time frame
Secondary end point(s): Maintenance of a minimum protective antibody titre (10 lU/L) in children who did not show an immune response (no measurable hepatitis B antibodies) after vaccination.;Timepoint(s) of evaluation of this end point: Maximum 9 months/patient	—

Countries

Hungary, Italy

Contacts

Public ContactMedical Affairs

Kedrion S.p.A.

a.lotti@kedrion.com0583 19696231 - 0583 1969601

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

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