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
- Conditions
- Prevention of hepatitis B recurrence after liver transplantation in patients who carry the surface antigen of the hepatitis B virus.MedDRA version: 6.1Level: PTClassification code 10019731
- Registration Number
- EUCTR2005-000840-10-IT
- Lead Sponsor
- KEDRIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method