EUCTR2010-018332-41-FI进行中（未招募）1 期
A Randomized, Open-label, Parallel Group, Multicenter Pilot Study Evaluating the Efficacy and Safety of Alternative Dosing of Ribavirin vs. Standard of Care Dosing in Combination with Peginterferon alpha-2a in Interferon Naïve Patients with Chronic Hepatitis C Genotype 1 Infection - RibaC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- •Written informed consent
- •Male and female patients<18 years of age
- •Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- •Serum HCV-RNA>15 IU/mL.
- •HCV genotype 1 infection confirmed within the past 2 years preceding the initiation of test drug dosing.
- •Compensated liver disease (Child-Pugh Grade A clinical classification)
- •Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan
- •without evidence of hepatocellular carcinoma and a serum AFP =100 ng/mL within 2 months of randomization
- •Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour
- •period prior to the first dose of study drug
- •All fertile males and females receiving ribavirin must be using effective contraception during treatment and
- •during 4 months for female patients / 7 months for male patients after end of treatment
- •Subject must weigh between 45 and 105 kg at screening
- •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
- •Women with ongoing pregnancy or breast feeding
- •IFN/ peg-interferon with or without ribavirin therapy at any previous time
- •Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including
- •supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
- •Any investigational drug ?6 weeks prior to the first dose of study drug.
- •HCV genotype 2, 3, 4, 5, 6, or 7 infection.
- •Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
- •Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis,
- •autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- •History or other evidence of decompensated liver disease
- •Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
- •Serum creatinine level >124 µmol/L or creatinine clearance =50 ml/minute at screening
- •Severe psychiatric disease, especially depression, as judged by the treating physician.
- •History of a severe seizure disorder or current anticonvulsant use
- •History of immunologically mediated disease, severe chronic pulmonary disease associated with functional
- •limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or
- •any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
- •Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological
- •disorder due to diabetes mellitus or hypertension
- •Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic
- •traditions.
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study
- •Male partners of women who are pregnant
- •Hemoglobin <120 g/L in women or <130 g/L in men at screening.
- •Any patient with an increased baseline risk for anemia (e.g. thalassemia major, spherocytosis, history of GI
- •bleeding, etc) or for whom anemia would be medically problematic coagulopathia.
- •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 40 g/L (as may be seen with ribavirin therapy) would not be well-tolerated.
研究者
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