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

NCT ID: NCT00838071

Last Updated: 2009-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2004-08-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IGIV-HB Grifols

Group Type: EXPERIMENTAL

Specific intravenous anti-hepatitis B immunoglobulin

Intervention Type: DRUG

Monthly doses of 5000 IU administered intravenously during 6 consecutive months

Interventions

Specific intravenous anti-hepatitis B immunoglobulin

Monthly doses of 5000 IU administered intravenously during 6 consecutive months

Intervention Type: DRUG

Other Intervention Names

Niuliva

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Instituto Grifols

Principal Investigators

Antoni Mas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Virgen del Rocío

Seville, Sevilla, Spain

Countries

Spain

Other Identifiers

IG301

Identifier Type: -

Identifier Source: org_study_id