ISRCTN59358441已完成不适用
Interferon (IFN) induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4
Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 58 人开始时间: 2006年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients which are serum HCV-RNA positive by PCR and with genotype 1 or 4
- •2. Patients who never have used antiviral therapy for chronic hepatitis C
- •3. Male and female patients =18 and <65 years of age
- •4. Patients who have given written informed consent after a detailed explanation of the study by the investigator
排除标准
- •1. Patients who are pregnant and patients (male or female) who are not willing to practice adequate contraception during the treatment period and up to 6 months after ending the treatment period
- •2. Patients who are HBsAg or human immunodeficiency virus (HIV) antibody positive or who are unwilling to have these tests done
- •3. Patients with decompensated cirrhosis (e.g. albumin <32 g/l, PTT prolonged >4 s, bilirubin 2 x upper limit of normal, AT III <60%, ascites, gastrointestinal [GI] bleeding, encephalopathy)
- •4. Patients with a history of intravenous (iv) drug use within 6 months prior to entry
- •5. Patients with any clinically significant systemic disease other than liver disease (e.g. malignant disease, congestive heart failure, uncontrolled diabetes mellitus, renal failure (serum creatinine >181 µmol/ml), or autoimmmune disease
- •6. Patients with a history of auto-immune hepatitis
- •7. Patients using immune modulating treatment during the 6 months prior to study entry
- •8. Patients with a history of hypersensitivity to any component of the study drugs
- •9. Patients with pre-existing bone marrow depression such as hematocrit <32%, white blood cell count <3.0 x 10^9/l, granulocytes <1.5 x 10^9/l, platelets <100 x 10^9/l, neutrophil count <1.5 x 10^9 or Hemoglobin <8.1 mmol/l for males and <7.0 mmol/l for females
- •10. Patients with severe depression or other psychiatric illness
- •11. Patients with a history of epilepsy, or other clinically significant central nervous system (CNS) dysfunction
- •12. Patients with any condition, that in the opinion of the investigator, might interfere with the outcome of the study
研究者
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