Chronic hepatitis C infection
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.(See Appendix X).
All patients
2 weeks Intron A (3X6 MU daily), Ribavir
Non-responders (group 1) and slow responders (group 2).
42 weeks: Pegylated Interferon 1.5 microgram/kg/week, Ribavirin 1000-1200 mg a day, Amantadine 200 mg a day.
Treatment will be stopped at week
Sponsors
Schering-Plough
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a chronic 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 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 < 3.0x10E9/l, granulocytes < 10%, platelets < 100x10E9/l Neutrophil count < 1.5x10E9 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 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. | — |
Contacts
Public ContactHuub C. Gelderblom
DDMRI, Level II, room 212 719 Umbilo Road Durban 4001
Outcome results
None listed