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

Information source: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B Liver Disease; Orthostotic Liver Transplant

Intervention: Hepatitis B immune globulin (Human) (Biological)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Biotest Pharmaceuticals Corporation


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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: April 2010
Last updated: June 29, 2010

Page last updated: August 23, 2015

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