Effect of ASV and DCV therapy on the quality of immune status in chronic HCV patientsInvestigator initiated research proposal nr. AI447-108 - Immuno Dual

Foundation for Liver Research0 个研究点开始时间: 2013年9月4日最近更新: 2014年1月27日

试验速览

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•Patients between 18 and 70 years of age, with a chronic hepatitis C – genotype 1b infection
•Patients are non-responders 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 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Decompensated cirrhosis (Child-Pugh Grade B or C)
•Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma within the last 3 months.
•Females who are pregnant or breast-feeding
•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 ASV and DCV:
•Interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week)
•Any exposure to NS3 protease inhibitors or NS5A polymerase inhibitors
•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