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Patterns of Early Hepatitis C Virus Decline Predict the Outcome of Interferon Therapy (sIFN-pred2) (sIFN-pred2)

2013年1月1日 更新者:Junqi Niu

Study of Parameters of Early Hepatitis C Virus Dynamics for Predicting the Outcome of Standard Interferon Therapy With Chinese Cohort (Second Phase)

The purpose of this study is to validate the first round HCV early dynamics discovery within a larger population.

研究概览

详细说明

Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. Combination therapy of ribavirin and interferons (IFN) is the standard clinical treatment of HCV chronical infections. However, overall rate of sustained virological response (SVR) still do not exceed 60% even with ribavirin and peg-IFN. Due to several virus- and patient-related factors, treatment is even less successful in certain populations, especially in HCV genotype 1 infection. Thus the standard therapy duration is optimized according to the virus genotype in the clinical practice. Nowadays, two direct antiviral agents (DAAs) have been approved by Food and Drug Administration (FDA) of USA this year, which increases the SVR rate. However, high price, side effects and long duration render people to hesitate about the addition of the third drug in the traditional prescription.

Predicting the outcome of traditional therapy is the cornerstone of the personalized therapy for HCV infected patients. In order to obtain an accurate prediction, different methods have been tried. Several indicators have been suggested to predict the final treatment outcomes. Rapid Virus Response (RVR), which indicates the non-detectable virus at the forth week since therapy starts, has been used to predict the final treatment outcome.Other indicators, including virus genotype, host genotype of IL-28B, human race and interferon stimulated genes (ISG) expression have also been shown to relate to and be able to predict the treatment outcomes to some extent. Here the investigators propose that the HCV virus dynamics analysis will give a more precise prediction for the therapy outcome.

The general idea is that blood HCV titration data is obtained continuously in the early treatment period (first 2 weeks) of the patients who have strictly followed the therapy method. These titration data will be used to draw virus dynamics curve and calculate the corresponding parameters individually. The parameter(s) that can distinguish patients who reach the therapy evaluation standard from those who failed to reach the evaluation standard will be selected out, and such parameter(s) may be used to predict the therapy outcome of a new patient in the early stage of his/her treatment.

研究类型

观察性的

注册 (预期的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Jilin
      • Changchun、Jilin、中国、130061
        • 招聘中
        • First Hospital Jilin University
        • 接触:
        • 接触:
        • 首席研究员:
          • Yu Pan, PhD/MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients are from the northeast of China. Most of the patients have been infected by the hepatitis c virus due to the drug abuse. Many of them share the same syringe for drug intravenous injection. However, HIV infection has been rarely detected.

描述

Inclusion Criteria:

  • Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
  • Serum HCV-RNA > 3 log IU/ml
  • Has been infected by HCV for more than 6 months
  • ALT,AST have been elevated continuously, inflammation and necrosis have been observed according to the histology diagnosis (G>=2),modest liver fibrosis (S>=2)For those patients whose ALT are normal,treatment accord to the liver biopsy. If obvious fibrosis has been detected (S2,S3),treatment should be done.For those S0,S1 stage patients, treatment could be delayed, but ALT/AST should be assayed every 3-6 months.
  • Compensated liver disease
  • Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

Exclusion Criteria:

-

History:

  • Has history of decompensated liver diseases
  • Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
  • Has a history of autoimmune hepatitis
  • History of a severe seizure disorder or current anticonvulsant use
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
  • History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

Current condition:

  • Pregnant women or women during the lactation period
  • Co-infected with hepatitis b virus or human immunodeficiency virus
  • Liver cancer or alpha-fetoprotein > 100ng/ml
  • Blood neutrophils count < 1500/mm3, or platelets count < 90000/mm3
  • Female hemoglobin <11.5g/dL, male hemoglobin <12.5g/dL
  • Blood creatinine > 1.5 ULN
  • Have severe mental diseases,especially depression
  • Severe pulmonary dysfunction
  • Severe cardiovascular disease
  • Uncontrolled diabetes
  • Uncontrolled thalassemia
  • Evidence of alcohol abuse (alcohol consumption>40 g/day)
  • Unwillingness to provide informed consent or abide by the requirements of the study
  • Local or System malignancy unstable status

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
干扰素和利巴韦林
所有患者均遵循标准治疗方案。

Interferon:dosage,5 million units/person;frequency,every other day (qod);duration,48 weeks;Subcutaneous injection.

Ribavirin: dosage,15mg/kg/day;frequency,three times a day (t.i.d);duration,48 weeks;take orally.

其他名称:
  • Other Names:IFN+Ribavirin
  • 仿制药:重组人干扰素 alpha-2b,利巴韦林
  • 品牌:凯音怡盛、唯乐克
  • FDA批准号:S20030032,H10940157

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Absolute Blood HCV RNA Copies at designed time points
大体时间:0hr,24hr,1wk,2wk,4wk,6wk,12wk,24wk,48wk,72wk
Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.
0hr,24hr,1wk,2wk,4wk,6wk,12wk,24wk,48wk,72wk

次要结果测量

结果测量
措施说明
大体时间
HCV基因型
大体时间:基线
将 HCV NS5A 克隆到 T 载体中并测序以进行进化分析。
基线
吸毒史
大体时间:基线
将询问患者他们的药物使用史。
基线
IL-28B多态性
大体时间:基线
IL28基因多态性,rs8099917,rs12979860等
基线
Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)
大体时间:Baseline,4wk,12wk,24wk,48wk
ALT AST are assayed to detect the hepatic function.
Baseline,4wk,12wk,24wk,48wk
Fibrosis stage
大体时间:Baseline,4wk,12wk,24wk,48wk
Fibrosis is analyzed with Fibroscan.
Baseline,4wk,12wk,24wk,48wk
Regular blood test
大体时间:Baseline,4wk,12wk,24wk,48wk
The distribution and absolute count of the different types of blood cells are assayed.
Baseline,4wk,12wk,24wk,48wk
Electrocardiography
大体时间:Baseline,4wk,12wk,24wk,48wk
Electrocardiography is taken to avoid severe side effects.
Baseline,4wk,12wk,24wk,48wk
Alcohol ,smoking condition
大体时间:Baseline,4wk,12wk,24wk,48wk
Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.
Baseline,4wk,12wk,24wk,48wk

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:Bing Sun, Doctor、Chinese Academy of Sciences
  • 研究主任:Chen Yang, Doctor、Chinese Academy of Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年7月1日

初级完成 (预期的)

2014年2月1日

研究完成 (预期的)

2014年3月1日

研究注册日期

首次提交

2012年9月8日

首先提交符合 QC 标准的

2013年1月1日

首次发布 (估计)

2013年1月4日

研究记录更新

最后更新发布 (估计)

2013年1月4日

上次提交的符合 QC 标准的更新

2013年1月1日

最后验证

2013年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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