Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Phase 3
Completed
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: Specific intravenous anti-hepatitis B immunoglobulin
- Registration Number
- NCT00838071
- Lead Sponsor
- Instituto Grifols, S.A.
- Brief Summary
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IGIV-HB Grifols Specific intravenous anti-hepatitis B immunoglobulin -
- Primary Outcome Measures
Name Time Method To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months. At months 4, 5, and 6
- Secondary Outcome Measures
Name Time Method To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols At months 1, 2, 3, 4, 5, and 6 To determine the incidence of recurrences during the treatment At months 1, 2, 3, 4, 5, and 6 To evaluate tolerance to the administration of HB-IVIG Grifols At months 1, 2, 3, 4, 5, and 6 To confirm the viral safety of the product supervising viral markers At months 1, 2, 3, 4, 5, and 6 To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose. At months 1, 2, 3, 4, 5, and 6
Trial Locations
- Locations (4)
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain