Study in which the effects on the immune system are examined of 2 direct acting antiviral drugs during the treatment of chronic hepatitis C patients

Conditions: Chronic hepatitis C
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-002991-42-NL

Lead Sponsor: Foundation for Liver Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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