Status:
COMPLETED
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
Lead Sponsor:
Foundation for Liver Research
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell response, due to continuous pressure of high viral load. Treatment of chronic HCV patients with ASV and DCV will re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02282709
Start Date
February 1 2014
End Date
July 1 2015
Last Update
October 19 2015
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE