EUCTR2006-002695-17-IT进行中（未招募）不适用
A multi-centre, randomised, double-blind, placebo-controlled escalating dose ranging phase II study on the efficacy of DEBIO-025 to reduce HCV viral load in combination with PEGASYS 180 g/week in treatment na ve patients with chronic hepatitis C and on the safety of this combination therapy - ND
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
- 90
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 Male or female patients 2 Age 8805;18 years and 8804;70 years; 3 Weight 8805;50 kg for women and 8805;60 kg for men; 4 Body mass index BMI between 8805;18 and 8804;29 5 HBs-Ag negative, HIV negative 6 Plasma HCV lower limit 8805;1000 IU/mL, no upper limit 7 Patients must be anti-HCV treatment na ve 8 White blood cell count 8805;3000/ L, Neutrophil count 8805;1500/ L, Hemoglobin 8805;100g/L, Platelets 8805;150 000/ L 9 Normal or compensated liver function as documented by the following a No history of esophageal varices bleeding, absence on physical examination of signs compatible with decompensated liver disease, such as ascites, jaundice, hepatic encephalopathy. b Albumin 8805; 35 g/L c Total Bilirubin 8804;1.2 mg/dL 8804;20 mol/L d Prothrombin INR 8804;1.2 e Aspartate aminotransferase ASAT , alanine aminotransferase ALAT 8804; 6 times the upper limit of normal ULN 10 All patients should be advised on the possible effects on foetotoxicity of DEBIO-025 and therefore restrain from reproductive activity a Females may participate if they are surgically sterile or postmenopausal. Pre-menopausal women may participate if they are abstinent or are compliant with a reliable contraceptive regimen. Abstinence or contraceptive regimen must be maintained during the treatment period and for 8 weeks after discontinuation of therapy. b Male patients must be surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during the treatment period and for 8 weeks after discontinuation of therapy. 11 Signed informed consent before entry into the study 12 Negative pregnancy test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 Ongoing or recent use of any anti-viral medication within one month before study start or within five drug half-lives of the investigational drug whichever is the longer 2 Ongoing or recent use of any other medication within 2 weeks before study start or within five drug half-lives of the investigational drug whichever is the longer 3 Presence of any severe concomitant disease cardiac, respiratory, gastrointestinal, renal, neurologic, psychiatric, infectious, bone, endocrine 4 For patients having in their previous history a documented liver biopsy, the presence of advanced inflammation, necrosis and fibrosis as expressed by one of the validated grading histology scores e.g. Scheuer Grade 4 for Necroinflammation and Fibrosis, Metavir Score A3F3 or superior, or equivalent score 5 Ultrasound or CT or MRI findings at screening with evidence of liver carcinoma or advanced liver fibrosis or biliary disease 6 Alfa fetoprotein exceeding 50 ng/mL; patients with values 20-50 ng/mL should have appropriate exclusion of liver carcinoma by US, CT or MR imaging 7 Arterial hypertension, i.e. patients with systolic blood pressure 8805;160 mmHg and/or diastolic blood pressure 8805;100 mmHg 8 Significant kidney impairment serum creatinine 8805; 2 times the ULN 9 Liver transplant recipient 10 Any concomitant disorder or resultant therapy that is likely to interfere with patient compliance or with the study procedures 11 Participation in another study with an experimental drug within three months before study start or within five drug half-lives of the investigational drug whichever is the longer 12 Known hypersensitivity to any of the test materials or related compounds
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