Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
研究概览
详细说明
The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to all patients with histologically documented hepatitis C recurring after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and irrespectively of the pattern of response to a previous antiviral treatment (if any).
The benefit will be assessed in terms of biochemical (normalization of serum transaminases levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of the histological signs of hepatitis) response. The presence of a sustained virological response, as defined below in section 6, will also be studied in relation to the early kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C patients, which suggest that an early rapid decrease of HCV viremia is associated with a durable response.
研究类型
注册
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 to 65 year old patients, male or female, having undergone a LT for end-stage liver disease due to HCV
- patients presenting after LT with recurrent HCV infection, documented by presence of HCV RNA in serum, and recurrent hepatitis, diagnosed at histology; the liver biopsy upon which the diagnosis is established must have been performed within the 12 months prior to inclusion; the treatment cannot start within the 6 months following LT
- alpha fetoprotein value within normal limits obtained within 3 months before entry visit
- stable immunosuppressive regimen, defined as lack of any therapeutic measures aimed at preventing or treating graft rejection during the three months prior to antiviral therapy
Exclusion Criteria:
- participation in other clinical trial within 30 days of entry into this protocol
- patients retransplanted for rejection or for recurrent hepatitis C on the graft
- patients with a history of cardiovascular disease including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure are excluded
- presence of HBsAg and/or HIV
- history of auto-immune disease, including auto-immune hepatitis
- alcohol consumption exceeding 40 grams per day
- acute rejection episode within the 3 months prior to inclusion, or current histological features possibly related to underlying rejection
- hepatocellular carcinoma
- unresolved biliary complication
- renal insufficiency (serum creatinine levels above 200 micromol/l)
- unconjugated bilirubin blood level > 100 micromol/l
- gammaglutamyl transferase > 20 times the upper limit of normal range
- prothrombin time below 60% of control (except in case of oral anti-coagulant therapy)
- neutrophil count less than 1,500/mm3
- platelet count less than 90,000/mm3
- hemoglobin below the lower limit of normal of the testing laboratory
- other organ or bone marrow transplantation
- current neoplasm and/or anti-tumor chemotherapy
- current hepatic arterial thrombosis
- pregnant or breast feeding women; child bearing potential women without adequate contraception throughout the course of therapy
- psychosis or anti-depressant therapy for uncontrolled clinical depression
- clinically significant retinal abnormalities
- thyroid dysfunction (abnormal TSH value with or without clinical symptoms)
- immunosuppressive therapy with OKT3 or any other anti-lymphocyte serum
- drug abuse (heroin, cocaine) or substitution therapy during the 12 months prior to inclusion
- history of ischemic cardiopathy
- interstitial pneumonitis
- previous auto-immune hemolysis and all causes of chronic hemolysis
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Biochemical (normalization of serum transaminases levels),
|
virological (disappearance of HCV RNA from serum)
|
and histological (amelioration of the histological signs of hepatitis) response.
|
次要结果测量
结果测量 |
---|
Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).
|
合作者和调查者
调查人员
- 首席研究员:Francesco Negro, MD、University Hospital, Geneva
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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丙型肝炎的临床试验
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Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
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Haisco Pharmaceutical Group Co., Ltd.完全的