Hepatitis B, Chronic
Conditions
Keywords
Chronic hepatitis B liver disease
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.
Interventions
BIOLOGICALNabi-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
Sponsors
Biotest Pharmaceuticals Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks. | 14 weeks |
Outcome results
None listed