EUCTR2009-012579-90-AT进行中（未招募）不适用
Antiviral effect and safety of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve patients for 12 or 24 weeks as combination therapy with pegylated interferon-a 2a and ribavirin (open label, randomised, Phase II)
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
- 140
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
- •1) Chronic hepatitis C infection of genotype 1 (1a, 1b or mixed 1a/1b) confirmed by
- •genotypic testing at screening
- •2) Therapy-naïve to interferon, pegylated interferon, and ribavirin
- •3) HCV viral load = 100.000 IU/ml at screening
- •4) Liver biopsy or fibroscan within two years prior to screening that provides
- •evidence of any degree of fibrosis or cirrhosis
- •5) Normal retinal finding on fundoscopy within 6 months prior to Day 1
- •6) Age 18 to 70 years
- •7) Female patients who are infertile or who are of childbearing potential with a
- •negative pregnancy test and agreeing to abstain from intercourse or to use one
- •accepted method of birth control in addition to the use of a condom
- •Male patients who are sterile, or who agree to abstain from intercourse or
- •who use a condom while their female partners use one medically accepted method
- •of birth control
- •8) Signed informed consent form prior to trial participation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by
- •genotypic testing at screening.
- •2) Patients who have been previously treated with at least one dose of any protease
- •inhibitor for acute or chronic hepatitis C infection
- •3) Evidence of liver disease due to causes other than chronic HCV infection
- •4) Positive for HIV-1 or HIV-2 antibodies
- •5) Hepatitis B virus (HBV) infection based on presence of HBs-Ag
- •6) Decompensated liver disease, or history of decompensated liver disease
- •7) Active or suspected malignancy or history of malignancy within the last 5 years
- •8) History of alcohol or drug abuse (except cannabis) within the past 12 months.
- •9) Body Mass Index < 18 or > 35 m2/kg.
- •10) Usage of any investigational drugs within 30 days prior to enrolment
- •11) Alpha fetoprotein value >100ng/mL at screening; if > 20ng/mL and = 100ng/mL,
- •if liver cancer is excluded
- •12) Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
- •13) ALT or AST level > 10 x ULN
- •14) TSH and T4 outside normal limits and not adequately controlled thyroid function;
- •15) Poorly controlled diabetes mellitus as evidenced by HbA1c > 7.5%
- •16) History of moderate, severe or uncontrolled psychiatric disease, especially
- •depression, including a history of hospitalisation or prior suicidal attempt;
- •17) Active autoimmune disease, including autoimmune hepatitis
- •18) Received concomitant systemic antiviral, hematopoietic growth factor, or
- •immunomodulatory treatment within 30 days prior to enrolment
- •19) Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 30
- •days prior to enrolment
研究者
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进行中（未招募）
不适用
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