NCT00838071已完成3 期
Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months.
研究概览
简要总结
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having undergone a liver transplantation due to liver disease associated with hepatitis B virus, at least 1 year before and no more than 5 years before inclusion in the study.
- •Patients who have required treatment with HBIG, or are receiving it at present.
- •Patients from 18 to 70 years of age.
- •The patient agrees to participate and comply with all aspects of the protocol, including the planned blood sample collection, and has signed the informed consent form.
排除标准
- •Presence of HBV DNA or HBeAg indicating virus replication.
- •Patients with known allergies to some component of HB-IVIG, such as sorbitol (e.g. patients presenting intolerance to fructose).
- •Patients with a known background of severe or frequent reactions to products derived from plasma.
- •Patients presenting arterial hypertension that is not clinically controlled.
- •Patients presenting a creatinine value >2 mg/dl, nephrotic syndrome or renal failure.
- •Patients presenting anaemia (haemoglobin < 11 g/dl).
- •Patients being treated with interferon.
- •The patient suffers some acute or chronic medical condition that the investigator believes may interfere with the development or interpretation of the study.
- •The patient is known to abuse of alcohol, opiates, psychotropic agents or other drugs or chemical substances; or has done so in the past 12 months.
- •Pregnant women at the time of inclusion or that may be pregnant in the next 7 months or breast-feeding women.
- •Patients participating in another clinical study, or who have received another investigational product in the last 3 months.
- •Possibility that the patient may be treated with other products containing immunoglobulins in a period of 7 months.
- •Suspicion of conditions that may affect the patient's compliance, including an expected survival of less than 1 year.
- •Any patient that does not have a frozen serum sample previous to the first study medication infusion.
- •Patients with selective IgA deficiency.
研究组 & 干预措施
IGIV-HB Grifols
Experimental
干预措施: Specific intravenous anti-hepatitis B immunoglobulin (Drug)
结局指标
主要结局
To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months.
时间窗: At months 4, 5, and 6
次要结局
- To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols(At months 1, 2, 3, 4, 5, and 6)
- To determine the incidence of recurrences during the treatment(At months 1, 2, 3, 4, 5, and 6)
- To evaluate tolerance to the administration of HB-IVIG Grifols(At months 1, 2, 3, 4, 5, and 6)
- To confirm the viral safety of the product supervising viral markers(At months 1, 2, 3, 4, 5, and 6)
- To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose.(At months 1, 2, 3, 4, 5, and 6)
研究者
研究点 (4)
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