Clinical trial NCT00838071: Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Official title: Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B
HBV
Anti-hepatitis B antibodies
Immunoglobulins
liver transplantation
Protective levels
Recurrence
Intravenous
Lead sponsor: Grifols Biologicals, LLC
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients who have required treatment with HBIG, or are receiving it at present.
3. Patients from 18 to 70 years of age.
4. 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:

1. Presence of HBV DNA or HBeAg indicating virus replication.
2. Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
3. Patients with a known background of severe or frequent reactions to products derived from plasma.
4. Patients presenting arterial hypertension that is not clinically controlled.
5. Patients presenting a creatinine value \>2 mg/dl, nephrotic syndrome or renal failure.
6. Patients presenting anaemia (haemoglobin \< 11 g/dl).
7. Patients being treated with interferon.
8. The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
9. 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.
10. Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
11. Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
12. Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
13. Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
14. Any patient that does not have a frozen serum sample previous to the first study medication infusion.
15. Patients with selective IgA deficiency.

Primary outcomes:
measure: 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.
timeFrame: At months 4, 5, and 6
Secondary outcomes:
measure: To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.
timeFrame: At months 1, 2, 3, 4, 5, and 6
measure: To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols
timeFrame: At months 1, 2, 3, 4, 5, and 6
measure: To determine the incidence of recurrences during the treatment
timeFrame: At months 1, 2, 3, 4, 5, and 6
measure: To evaluate tolerance to the administration of HB-IVIG Grifols
timeFrame: At months 1, 2, 3, 4, 5, and 6
measure: To confirm the viral safety of the product supervising viral markers
timeFrame: At months 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Antoni Mas, MD
role: PRINCIPAL_INVESTIGATOR
References: