A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir®, in Orthotopic Liver Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 43
- 主要终点
- Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 22 weeks post transplant
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
详细描述
Civacir® 10%, Hepatitis C Immune Globulin Intravenous (Human) is a high-titer human polyclonal immune globulin (IgG) containing a diversity of antibodies that target and bind the hepatitis C virus (HCV) to prevent infection. Subjects who reduce their viral load to less than 100 IU/ml HCV RNA through up to 24 weeks of antiviral therapy prior to liver transplant are enrolled in the study. There is no requirement to reach undetectable virus prior to transplant as the function of Civacir® is to neutralize any remaining virus in circulation.
Subjects randomized to Civacir® treatment arms receive study drug infusions starting on the day of liver transplant followed by 15 doses over a 10 week period to prevent the recurrence of quantifiable Hepatitis C Virus (HCV) after liver transplant. The study will evaluate dosing arms ranging from 200 mg/kg to 300 mg/kg compared to a control arm. For the primary endpoint, efficacy is defined as persistent viral load suppression maintaining HCV RNA levels below the lower limit of quantitation as determined by central laboratory Polymerase Chain Reaction (PCR) at 22 weeks post-liver transplant and then at 34 weeks post-liver transplant to demonstrate durability of effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to any study-specific assessments and within 3 months (reconsent) of orthotopic liver transplantation (OLT).
- •HCV Genotype 1 through 6 Infection.
- •Subjects in the beginning of a new antiviral therapy regimen (regardless of prior treatment failures) for up to and including 24 weeks prior to the day of OLT.
- •Most recent evidence within the last 4 weeks that HCV RNA is <100 IU/mL. Subjects may be randomized based on local lab HCV RNA.
- •Male and female subjects (age 18-80 years).
- •Subject weight under 250 pounds.
- •Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study.
排除标准
- •Re-transplantation due to viral recurrence.
- •Positive HIV or HBV test within 90 days prior to transplantation.
- •Most recent PCR test indicating HCV RNA ≥100 IU/mL within 4 weeks of OLT.
- •Subjects having received organs from HCV positive donors.
- •Serum creatinine level >2.5 times the upper limit of normal or advanced renal disease at screening.
- •Pregnancy or single contraceptive measure or lactation period (females only).
- •Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction).
- •Known absolute Immunoglobulin A (IgA) deficiency.
- •Known intolerance to proteins of human origin.
- •Participation in another clinical trial within 90 days before signing Informed Consent Form (ICF) or during the study (observational/ non-interventional and 988 studies allowed), and/or previous participation in 988 study (except for Study 988 screen failures).
- •Active drug and/or alcohol abuse.
- •Inability or lacking motivation to participate in the study.
结局指标
主要结局
Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 22 weeks post transplant
时间窗: 22 weeks
The primary objective is to assess the effect of administering Civacir® anti-HCV immunoglobulin therapy on prevention of orthotopic liver transplant (OLT) HCV recurrence, as measured by the proportion of subjects with unquantifiable HCV RNA levels at 22 weeks post-OLT, compared to the control group (not treated with Civacir® and considered standard of care).
次要结局
- Determine the efficacy of Civacir® in preventing post-transplant HCV recurrence at 4 and 34 weeks post transplant(34 weeks)