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

Information source: Grifols Biologicals Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Specific intravenous anti-hepatitis B immunoglobulin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Instituto Grifols, S.A.

Official(s) and/or principal investigator(s):
Antoni Mas, MD, Principal Investigator, Affiliation: Hospital Clínic de Barcelona

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.

To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols

To determine the incidence of recurrences during the treatment

To evaluate tolerance to the administration of HB-IVIG Grifols

To confirm the viral safety of the product supervising viral markers

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Hospital Clínic de Barcelona, Barcelona 08035, Spain

Hospital Vall d'Hebron, Barcelona 08035, Spain

Hospital Universitario 12 de Octubre, Madrid 28041, Spain

Hospital Virgen del Rocío, Sevilla 41013, Spain

Additional Information

Starting date: October 2003
Last updated: February 5, 2009

Page last updated: August 20, 2015

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