Chronic hepatitis C
Conditions
Interventions
Product Name: HCV NS5A Replication Co-factor Inhibitor
Product Code: Daclatasvir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: daclatasvir
CAS Number: 1009119-64-5
Current Sponsor code:
Sponsors
Foundation for Liver Research
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before, during and after treatment with ASV and DCV, in an IFN-free regimen.;Secondary Objective: 1. To determine the phenotype and function of blood leukocytes during treatment; with focus on T cells, NK cells and monocytes 2. To determine the gene expression profiles of blood leukocytes before, during and after treatment 3. To determine the effect of ASV and DCV treatment on the activation of the type I IFN signalling pathway and the levels of immune markers 4. To determine the differences in immune cells between responders and relapsers by assessing the phenotype and function of blood leukocytes during treatment; with focus on T cells, NK cells and monocytes, as well as gene expression profiles. In addition, serum cytokines using multiplex platforms could be included in the analysis. ;Primary end point(s): HCV-RNA negativity 24 weeks after the end of treatment (sustained viral response);Timepoint(s) of evaluation of this end point: 24 weeks follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HCV-RNA negativity 8 weeks during treatment;Timepoint(s) of evaluation of this end point: 8 weeks during treatment | — |
Countries
Netherlands
Contacts
Public ContactR.J. de Knegt
Foundation for Liver Research
Outcome results
None listed