Hepatitis C Infections and Infestations Hepatitis C
Conditions
Interventions
This study will be an open pilot study. Data will be analysed on an intention to treat basis.
Eighty patients will be included.
All patients:
2 weeks In
Sponsors
Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a chronic hepatitis C virus (HCV) infection, with virological relapse, or with virological non response to previous antiviral therapy diagnosed by a. Anti-HCV positive b. Serum HCV-RNA positive by polymerase chain reaction (PCR) 2. Patients who have not used antiviral or immune modulating therapy, including interferon, in the previous 6 months 3. Male and female patients >18 and <65 years of age 4. Patients who have given written informed consent after a detailed explanation of the study by the investigator
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant and patients (male or female) who are not willing to practise adequate contraception during the treatment period and up to 6 months after ending the treatment period 2. Patients who are HBsAg or HIV antibody positive or are unwilling to have these tests done 3. Patients with decompensated cirrhosis (e.g. albumin 4 s, bilirubin > upper limit of normal, AT III 181 micromol/ml], or autoimmmune disease) 6. Patients with a history of auto-immune hepatitis 7. Patients using immune modulating treatment during the 6 months prior to study entry 8. Patients with a history of hypersensitivity to any component of the study drugs 9. Patients with pre-existing bone marrow depression such as hematocrit <32%, white blood cell count <3.0 x 10^9/l, granulocytes <10%, platelets <100 x 10^9/l, neutrophil count <1.5 x 10^9 or Hemoglobin <8.1 mmol/l for males and <7.5 mmol/l for females 10. Patients with severe depression or other psychiatric illness 11. Patients with a history of epilepsy, or other clinically significant central nervous system (CNS) dysfunction 12. Patients with any condition, that in the opinion of the investigator, might interfere with the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if initial drop in viral load is predictive for virological sustained response. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if other co-factors i.e. viral load or HCV genotype are predictive for sustained virological response. | — |
Countries
Netherlands
Outcome results
None listed