Effect of Telaprevir in triple therapy for chronic hepatitis C patients on Intrahepatic immunological Mechanisms - ETIM

Foundation for Liver Research0 个研究点目标入组 25 人开始时间: 2011年12月23日最近更新: 2013年4月29日

试验速览

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•Patients between 18 and 70 years of age, with a chronic hepatitis C – genotype 1 infection.
•Patients are naive, non-responders or relapsers to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy.
•High viral load (>400,000 IU/ml)
•Indication for antiviral therapy of hepatitis C according to current clinical guidelines.
•Written informed consent.
•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 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Signs of progressive liver disease, beyond generally accepted criteria for HCV antiviral therapy
•History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
•Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV).
•Presence of contra-indications for antiviral therapy with telaprevir, peginterferon or ribavirin.
•Interfering substance abuse, such as alcohol (indicator: 28 drinks/ week).
•Earlier treatment with a protease/polymerase inhibitor or treatment with peginterferon/ ribavirin within 6 months before start of therapy
•Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study.

发起方

Foundation for Liver Research