Status:
COMPLETED
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Lead Sponsor:
Instituto Grifols, S.A.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 globu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00838071
Start Date
October 1 2003
End Date
August 1 2004
Last Update
February 6 2009
Active Locations (4)
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1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08035
2
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
3
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
4
Hospital Virgen del Rocío
Seville, Sevilla, Spain, 41013