EUCTR2011-002911-27-IT进行中（未招募）不适用
Effect of boceprevir therapy on HCV-specific T cell responses: perspectives of immune monitoring and immune therapy - Boceprevir therapy and HCV-specific T cell responses
AZIENDA OSPEDALIERA DI PARMA0 个研究点目标入组 30 人开始时间: 2011年7月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •· Male or female, aged from 18 to 70 years old, inclusive. · Willing and able to provide written informed consent · Chronic HCV infection for at least 6 month prior to baseline (Day 1) in subjects currently positive for HCV-RNA and anti-HCV antibody documented by: · A positive anti-HCV antibody test, positive HCV-RNA assay, or HCV genotype test at least 6 month prior to baseline (Day 1) or · Subjects must have liver biopsy results (performed no more than two years prior the screening) indicating the absence of cirrhosis · HCV infection limited to genotype 1 · Detectable plasma HCV-RNA at screening · BMI between 18 and 36 Kg/m2 · Eligible subjects must also be HCV treatment-naïve, defined as no prior exposure to PEG-INF and ribavirin, and must be eligible to standard of care therapy with PEG/RBV · Subjects must have the following laboratory parameters at screening: ALT and AST £ 5 x upper limit of normal range (ULN) Hemoglobin (Hb) ³ 12 g/dl WBC ³ 2.500 cells/mL with absolute neutrofil count ³ 1500 cells/mL If a woman of childbearing potential, must have negative serum b-human chorionic gonadotropin (b-HCG) pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment A female subjects of childbearing potential and nonvasectomized male subjects with a female partners of childbearing potential must agree that they and their partner will use effective contraception (two separate forms of contraception simultaneously, one of which must be a male condom with spermicide) from screening throughout the duration of study treatment and for at least 7 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •· Pregnant women or women who may wish to become pregnant during the course of the study · Male with a female who is pregnant or is planning to become pregnant within seven month the study of anticipated last dose of ribavirin · Evidence of infection or co-infection with a no-genotype 1 HCV-strain · History of hemoglobinopathy · History of sarcoidosis · History of invasive malignancy diagnosed or treated within 5 years. · Untreated or significant psychiatric illnesses including severe depression, schizophrenia, psychosis, history of a suicide attempt · Co-infection with HBV or HIV · Chronic use of systemic immunosuppressive agents · Presence of autoimmune disorders; subjects with treated hypothyroidism with normal TSH may be enrolled · History of significant cardiac disease · Clinical evidence of chronic pulmonary disease · Known cirrhosis · History of solid organ transplantation · Suspicion of hepatocellular carcinoma · Chronic liver disease of a non-HCV etiology · Ongoin alcohol abuse · History of clinical relevant drug abuse · Positive urine screen for cocaine, opiate etc, or methadone use
研究者
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