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.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
The following questions will be addressed in this study:
1. Does the reduction in viral load due to dual therapy with ASV and DCV affect
the immune status of patients chronically infected with HCV?
2. Does the reduction in viral load due to dual therapy with ASV and DCV
restore impaired immune responses to HCV?
Secondary outcome
not applicable.
Background summary
Worldwide approximately 170 million people are infected with the hepatitis C
virus (HCV). Current treatment consists of peginterferon and ribavirin which
ensures a sustained viral response (SVR) in approximately 50% of patients with
genotype 1. Recently, telaprevir or boceprevir was added to this treatment, but
there are many side effects as a result of the activity of of interferon in the
therapy. With this research we want to study two novel antiviral compounds, ASV
and DCV, that act directly on inhibiting the replication of the virus.
Study 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
Single center, open label study with one arm of 12 patients.
Patients are between 18 and 70 years of age, with a chronic hepatitis C -
genotype 1b infection.
Study burden and risks
The risk and discomforts experienced during participation to the study
(treatment and extra blood collection) are minimal.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-002991-42-NL |
| CCMO | NL45667.078.13 |