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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Following the last IV administration of HBIG, have a baseline serum anti-HBs level of >150 IU/ML prior to dosing at visit
- •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
- •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
- •(except low dose glucocorticoid therapy, <10 mg of prednisone or equivalent per day.)
- •received and investigational drug 30 days prior to visit
- •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.
排除标准
- 未提供
结局指标
主要结局
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.
时间窗: 14 weeks
次要结局
- To evaluate the safety of Nabi-HB administered subcutaneously weekly for a total of 14 weeks.(14 weeks)