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This study evaluates the effect of Daclatasvir and asunaprevir treatment on the immune status of patients with chronic hepatitis C (genotype 1b). Adults aged 18-70 with chronic hepatitis C who did not respond to previous interferon-based therapy and who have a high viral load were able to take part. The study was carried out in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 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