EUCTR2013-000245-39-AT进行中（未招募）不适用
Rescue effect of daily infusions with Legalon® SIL in Hepatitis C Virus-infected patients who are incomplete responders to standard pegylated interferon/ribavirin (dual therapy) or pegylated interferon/ribavirin plus a protease inhibitor (triple therapy): a randomized, controlled, parallel-group, multicenter clinical trial. - Silibinin as an ANtiviral Treatment Enhancement to a standard antiviral combination therapy (SANTÉ)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients meeting all the following inclusion criteria will be eligible for enrollment in the study:
- •1.Signed and dated informed consent obtained before undergoing any trial-specific procedure
- •2.Male and female patients; age between 18 and 70 years inclusive
- •3.Chronic hepatitis C infection with genotype confirmed by genotypic testing
- •4.Meeting a predefined virologic stopping rule to an ongoing standard of care antiviral treatment regimen [containing pegylated interferon-a 2a/b and ribavirin either alone (dual therapy) or in combination with selective HCV protease inhibitors (triple therapy)]
- •5.detectable HCVRNA levels at the time of screening as follows: - for the Group 1: GT1 patients with HCV-RNA =10.000 IU/mL; - for the Exploratory Group (Group 2): GT1 patients with HCV-RNA >10.000 IU/mL but =30.000 IU/mL and any non-GT1 patient =30.000 IU/mL.
- •6.Ability to communicate, participate, and comply with the requirements of the entire study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Disease related criteria:
- •1.Co-Infection with HIV and/or HBV
- •2.Evidence or history in the previous 5 years of deconpensated liver cirrhosis as signs of ascites, esophageal varices or laboratory abnormalities that indicate impaired liver function
- •3.Evidence of liver disease due to causes other than chronic HCV infection
- •4.Bilirubin levels > 2.0 mg/dL unless explained by Gilbert’s disease
- •5.Platelet Count < 50.000/µL
- •6.Absolute Neutrophil count < 750/µL (mm3)
- •Patient related criteria:
- •1.Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years
- •2.Clinically significant TSH and T4 level and not adequately controlled thyroid function
- •3.Patients with any abnormality on laboratory value, unless these abnormalities are judged to be not clinically significant by the Investigator
- •4.Patients with any abnormality on physical examination, and/or ECG, unless these abnormalities are judged to be not clinically significant by the Investigator
- •5.Body Mass Index < 16 or > 35 kg/m2
- •6.Females of childbearing potential:
- •-Pregnancy (i.e. positive pregnancy test at screening) or lactation
- •-Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device [IUD], transdermal contraceptive patch)
- •7.Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom
- •8.Use of concomitant medication that is not allowed and that cannot be discontinued for the entire study period
- •9.Use of other investigational drugs/treatments, or enrolment in a clinical study within the previous 3 months or 5 half lives (whichever is longer), except for investigational drug/treatments for HCV
- •10.Known hypersensitivity to any of the test materials or related compounds
- •11.Use of illicit drugs or significant alcohol abuse within the past 12 months. Use of cannabis is not exclusionary
- •12.Active autoimmune disease
- •13.History of moderate, severe or uncontrolled psychiatric disease, especially severe depression and prior suicidal attempt
- •14.Poor venous access
- •15.Patients with Creatinin >1,5 ULN
- •16.Any other condition that, in the opinion of the Investigator, may jeopardize the study conduct according to the protocol.
研究者
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