EUCTR2013-003729-27-GB进行中（未招募）1 期
Telaprevir in patients with genotype 3 HCV : pilot clinical study to evaluate efficacy and predictability of therapy in patients who have failed to respond to pegylated interferon and ribavirin - Telaprevir in genotype 3 HCV
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
- 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
- •Patients with genotype 3 HCV and advanced fibrosis - defined as a liver biopsy within 2 years showing an Ishak fibrosis score of >4 OR rdiological evidence of cirrhosis (ultrasound scan or fibroscan reading >10.6)
- •Previous therapy with pegylated interferon and ribavirin for at least 24 weeks with undetectable HCV RNA at the end of therapy and detectable HCV RNA six months after treatment cessation
- •Chronic genotype 3 HCV infection, RNA positivity with genotype 3 infection confirmed at a local laboratory.
- •HBsAg negative and no clinical evidence of co-infection with HIV
- •Platelet count >20,000 cells/mm3, Neutrophil count > 600 cells/mm3
- •Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
- •Able and willing to give informed consent and able to comply with study requirements
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Evidence of other cause of significant liver disease – serum ferritin > 1000, biochemical evidence of Wilson’s disease, autoantibody titres in excess of 1:160
- •Poorly controlled diabetes that, in the investigators opinion, precludes therapy
- •Severe retinopathy that, in the opinion of the investigator, precludes therapy
- •Haemoglobin concentration <11 g/dL in females or <12 g/dL in males or any patient with an increased risk for anaemia (e.g., thalassemia, sickle cell anaemia, spherocytosis, history of gastrointestinal bleeding) or for whom anaemia would be medically problematic
- •Females who are pregnant or breast-feeding
- •History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease within the last 2 years
- •History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis (defined as affecting >10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management
- •Other on-going serious medical condition in the opinion of the investigator that would prohibit treatment
- •Poorly controlled thyroid dysfunction
- •History of major organ transplantation with an existing functional graft
研究者
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