NCT02282709

Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 result in a significant drop in HCV viral load. At present, no information is available on the immunological effects of treatment with ASV and DCV, nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects. This information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound or relapses during, at the end of treatment or during the follow up period. 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. Study design: This is an investigator-initiated single center open label study with one arm of 12 patients. Study population: Adult chronic HCV patients with genotype 1b, who are previous non-responders to the treatment. Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks. Main study parameters/endpoints: 1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T cells, NK cells and monocytes 2. Gene expression levels of leukocyte populations before, during and after treatment 3. Gene expression levels of the type I IFN signaling pathway on whole blood samples 4. Serum cytokines levels using multiplex platforms

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Daclatasvir	60 mg once daily
DRUG	asunaprevir	100 mg BID

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-11-04
• Last updated: 2015-10-19

Locations

1 site across 1 country: Netherlands