Open Label Phase II Multicenter Study for the Evaluation of Pharmacokinetics of VENBIG (Human Immunoglobulin anti-Hepatitis B for Intravenous Use) and IMMUNOHBS (Human Immunoglobulin anti Hepatitis B for Intramuscular Use) Administered to HBsAg Negative Patients After Orthotopic Liver Transplantation. Evaluation of Safety and Efficacy of IMMUNOHBS performed in all the patients enrolled in the Pharmacokinetic Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000840-10-IT

Enrollment

Registered

2005-08-25

Start date

2005-09-19

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Prevention of hepatitis B recurrence after liver transplantation in patients who carry the surface antigen of the hepatitis B virus. MedDRA version: 6.1 Level: PT Classification code 10019731

Interventions

Trade Name: VENBIG*500UI/10ML IV FL+FL Product Name: NA Product Code: NA Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Hepatitis B immunoglobulin Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

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