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

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838071
• Other study ID #: IG301
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2009
• Last updated: February 5, 2009
• Start date: October 2003
• Est. completion date: August 2004

Study information

• Verified date: February 2009
• Source: Grifols Biologicals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Specific intravenous anti-hepatitis B immunoglobulin
Monthly doses of 5000 IU administered intravenously during 6 consecutive months

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		At months 4, 5, and 6	No
Secondary	To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.		At months 1, 2, 3, 4, 5, and 6	No
Secondary	To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols		At months 1, 2, 3, 4, 5, and 6	No
Secondary	To determine the incidence of recurrences during the treatment		At months 1, 2, 3, 4, 5, and 6	No
Secondary	To evaluate tolerance to the administration of HB-IVIG Grifols		At months 1, 2, 3, 4, 5, and 6	Yes
Secondary	To confirm the viral safety of the product supervising viral markers		At months 1, 2, 3, 4, 5, and 6	Yes