Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load
Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma
(HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The
prevention of HCV transmission and early intervention of HCV infection are urgently needed to
reduce or halt the liver-related morbidity and mortality. Double filtration plasmapheresis
(DFPP) has been with widespread use in clinical practice for several indications with plasma
filters optimized for the respective elimination targets with excellent safety. By way of the
plasma separator, the blood is separated into plasma and cell components. Separated plasma is
then led into the plasma component separator where the pores of the plasma component
separator further fractionate the plasma into large and small molecular components. The large
molecular components, including pathogenic substances, is removed and discarded and the small
molecular components, including proteins such as albumin and gamma-globulin, are returned to
the patient and mixed with the cell components. After the initiation of pegylated interferon
plus ribavirin (Peg-IFN+RBV) therapy, the rapid first phase relates to a significant
reduction in virus production and the degradation of free virus particles, which is followed
by a second much slower one reflecting the elimination and clearance of infected cells. In
HCV patients, high baseline viral load at the initiation of therapy is considered to be a
negative predictor for systemic vascular resistance (SVR) for HCV genotype 1 patients.
Reduction of baseline viral load by means of therapeutic double filtration plasmapheresis
(DFPP) may represent a plausible adjunct for improved antiviral therapy to reduce the virus
load with the initiation of treatment in synergy with Peg-IFN and RBV combination therapy.
Recently, several clinical studies in evaluating the therapeutic efficacy and safety of DFPP
in conjunction with IFN-based therapy were conducted for treatment-naïve genotype 1 high
viral load CHC patients, and CHC patients who underwent liver transplantation. These studies
showed that patients with DFPP treatment had more favorable HCV early viral kinetics to those
without DFPP treatment. Furthermore, all these studies showed excellent safety after DFPP
treatment. Therefore, the investigators aimed to conduct a large-scaled randomized controlled
trial to evaluate the overall response of DFPP for HCV genotype 1 patients with high viral
load.
Phase:
Phase 4
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborators:
Department of Health, Executive Yuan, R.O.C. (Taiwan) National Science Council, Taiwan