Nabi-HB-SC: Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation

Sponsor

Biotest Pharmaceuticals Corporation (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00800787

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic	Biological: Nabi-HB	Phase 3

Detailed Description

This is a phase 3 prospective, single arm open label study to be conducted t approximately 4 study sited located in th e USA. Approximately 25 HBV DNA negative patients who underwent liver transplant at least one year prior, due to chronic hepatitis B infection will bwe eligible for study participation. The study consist of a total of 16 study visit and the duration of participation will be 20 weeks for each patients. Patients will be converted from the intravenous standard HBIG to Nabi-HB subcutaneous administration according to the individual scheduled dosing interval.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Multicenter, Open Label Study to Assess the Safety and Efficacy of Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Associated Liver Disease Who Underwent Liver Transplantation

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm One: Nabi-HB All subjects will be administered Nabi HB Subcutaneously	Biological: Nabi-HB Hepatitis b Immune Globulin (Human)(Nabi-HB) 312 IU/L per dose administered subcutaneously. Dosage will be according to each patients body weight, as follow: < 75 kg: 500 IU weekly ( may be increase to 1,000 IU weekly if anti-HBs levels are <150 IU/ML > 75 Kg: 1,000 IU weekly Other Names: Hepatitis B Immune Globulin (Human)

Arm

Intervention/Treatment

Experimental: Arm One: Nabi-HB

All subjects will be administered Nabi HB Subcutaneously

Biological: Nabi-HB

Hepatitis b Immune Globulin (Human)(Nabi-HB) 312 IU/L per dose administered subcutaneously. Dosage will be according to each patients body weight, as follow: < 75 kg: 500 IU weekly ( may be increase to 1,000 IU weekly if anti-HBs levels are <150 IU/ML > 75 Kg: 1,000 IU weekly

Other Names:

Hepatitis B Immune Globulin (Human)

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of Nabi-HB administered subcutaneously weekly for a total of 14 weeks in patients who previously underwent a liver transplant. Levels will provide evidence if effective anti-HB levels >150 IU/ML can be maintained. [14 weeks]

Secondary Outcome Measures

To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks. [14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients 18 years old or older as of visit one.
If female is not trying to conserve, not lactating, and has a negative serum pregnancy test and use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile.
Able to provide written informed consent.
First time liver transplant recipient.
Primary, single organ recipient (deceased donor <65 years old).
receive regular long-term HBIG prophylaxis with stabilized HBIG dosage and administration intervals.
Have negative quantifiable HBV-DNA and HBsAg results prior to dosing at visit 2.
Following the last IV administration of HBIG, have a baseline serum anti-HBs level of

150 IU/ML prior to dosing at visit 2.

Exclusion Criteria

Positive HCV or HIV test results.
Unexplained elevated liver function tests.
Serum creatinine level >2.0 times the upper limit of normal.
life expectancy <6 months.
liver transplantation with ongoing acute rejection episode. Donor liver that was from a hepatitis Bor C positive donor. Underwent a liver transplant <12 months prior to visit 1.
Know history of cancer, suspected cancer, or cancer therapy within 12 months.
History of autoimmune disease.
History/current evidence of coagulation disorder, severe cardiac disease, unhealed gastric or duodenal ulcer, or other significant disease.
Evidence of any other unresolved infection and any unresolved opportunistic infection requiring treatment.
Known immunoglobulin A deficiency.
History of use of immunosupressive or immunomodulatory drug within 3 month prior to visit 1. (except low dose glucocorticoid therapy, <10 mg of prednisone or equivalent per day.)
received and investigational drug 30 days prior to visit 1.
use of plasma preparations or other immunoglobulins during the study.
Know intolerance to proteins of human origin, immunoglobulin, or comparable products.
Evidence of alcohol and/or drug abuse within 6 month of visit 2 or inability/unwillingness to abstain from alcohol for the duration of the study.