Study to evaluate different duration of treatment regimes of 40kD pegylated interferon alfa 2a (Pegasys) plus ribavirin on sustained virological responses (SVR) in Genotype 3 HCV infected cirrhotic patients - STEPS in Geno 3 Cirrhotics

Queen Mary University of London0 个研究点目标入组 0 人开始时间: 2008年3月25日最近更新: 2019年11月25日

适应症

试验速览

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•Chronic genotype 3 HCV infection as evidenced by HCV antibody and RNA positivity with genotype 3 infection confirmed at a central laboratory.
•Liver biopsy within 18 months of entry showing features of chronic HCV infection and modified Ishak fibrosis score of equal to or greater than 4 OR radiological and/or endoscopic features of cirrhosis.
•HBsAg negative,
•No clinical evidence of co-infection with HIV
•Platelet count =30,000 cells/mm3, Neutrophil count > 600 cells/mm3
•Compensated liver disease (Child-Pugh Grade A clinical classification – Appendix 2)
•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) no
•F.1.3.1 Number of subjects for this age range

•Previous therapy for chronic HCV infection -interferon alpha (IFN), PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors
•Patients who are expected to need alternative antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excluded
•Evidence of other cause of significant liver disease – serum ferritin > 1000, biochemical evidence of Wilson’s disease, autoantibody titres in excess of 1:160
•Platelet count < 30,000 cells/mm3, Neutrophil count = 600 cells/mm3
•Poorly controlled diabetes that, in the opinion of the investigator, precludes therapy
•Severe retinopathy that, in the opinion of the investigator, precludes therapy
•Decompensated cirrhosis (Childs Pugh B or C)

发起方