ISRCTN81536220已完成未知
Retreatment of chronic hepatitis C patients with pegylated interferon (IFN), ribavirin and amantadine; a pilot study to establish if initial drop in viral load is predictive for sustained virological response
Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)0 个研究点目标入组 100 人开始时间: 2006年2月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2008 results in https://pubmed.ncbi.nlm.nih.gov/18584525/ (added 25/02/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with a chronic hepatitis C virus (HCV) infection, with virological relapse, or with virological non response to previous antiviral therapy diagnosed by
- •a. Anti-HCV positive
- •b. Serum HCV-RNA positive by polymerase chain reaction (PCR)
- •2. Patients who have not used antiviral or immune modulating therapy, including interferon, in the previous 6 months
- •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 practise adequate contraception during the treatment period and up to 6 months after ending the treatment period
- •2. Patients who are HBsAg or HIV antibody positive or are unwilling to have these tests done
- •3. Patients with decompensated cirrhosis (e.g. albumin <32 g/l, PTT prolonged >4 s, bilirubin > 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 micromol/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 <10%, platelets <100 x 10^9/l, neutrophil count <1.5 x 10^9 or Hemoglobin <8.1 mmol/l for males and <7.5 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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