Clinical trial NCT00800787: Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Keywords: Chronic hepatitis B liver disease
Lead sponsor: Biotest Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 14 weeks
Secondary outcomes:
measure: To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.
timeFrame: 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Shailesh Chavan, MD
role: STUDY_DIRECTOR
References: