Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation

Inclusion criteria

• Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
• Patients who have required treatment with HBIG, or are receiving it at present.
• Patients from 18 to 70 years of age.
• The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.

Exclusion criteria

• Presence of HBV DNA or HBeAg indicating virus replication.
• Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
• Patients with a known background of severe or frequent reactions to products derived from plasma.
• Patients presenting arterial hypertension that is not clinically controlled.
• Patients presenting a creatinine value >2 mg/dl, nephrotic syndrome or renal failure.
• Patients presenting anaemia (haemoglobin < 11 g/dl).
• Patients being treated with interferon.
• The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
• The patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months.
• Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
• Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
• Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
• Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
• Any patient that does not have a frozen serum sample previous to the first study medication infusion.
• Patients with selective IgA deficiency.