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

Primary Purpose

Hepatitis B, Chronic

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Specific intravenous anti-hepatitis B immunoglobulin

About this trial

This is an interventional prevention trial for Hepatitis B, Chronic focused on measuring Hepatitis B, HBV, Anti-hepatitis B antibodies, Immunoglobulins, liver transplantation, Protective levels, Recurrence, Intravenous

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Clínic de Barcelona
Hospital Vall d'Hebron
Hospital Universitario 12 de Octubre
Hospital Virgen del Rocío

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IGIV-HB Grifols

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT00838071

First Posted

February 5, 2009

Last Updated

February 5, 2009

Sponsor

Instituto Grifols, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT00838071

Brief Title

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

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

July 2004 (Actual)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Instituto Grifols, S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

Keywords

Hepatitis B, HBV, Anti-hepatitis B antibodies, Immunoglobulins, liver transplantation, Protective levels, Recurrence, Intravenous

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IGIV-HB Grifols

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Specific intravenous anti-hepatitis B immunoglobulin

Other Intervention Name(s)

Niuliva

Intervention Description

Monthly doses of 5000 IU administered intravenously during 6 consecutive months

Primary Outcome Measure Information:

Title

Time Frame

At months 4, 5, and 6

Secondary Outcome Measure Information:

Title

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

Time Frame