Interferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4.

Interferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4; Pilot study to establish if initial drop in viral load is predictive for sustained virological response.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27278

Enrollment

Registered

2006-01-04

Start date

2002-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis C

Interventions

All patients will be treated for 24 or 48 weeks. Patients who achieve a 3log drop in viral load after 4 weeks of treatment will be randomized to stop treatment early after 24 weeks or continue to 48 w

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients which are serum HCV-RNA positive by PCR and with genotype 1 or 4; 2. Patients who never have used antiviral therapy for chronic hepatitis C; 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 practice 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 who are unwilling to have these tests done; 3. Patients with decompensated cirrhosis (e.g. albumin 4 s, bilirubin 2x > 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 < 1.5x10E9/L, platelets < 100x10E9/L neutrophil count < 1.5x10E9 or Hemoglobin < 8.1 mmol/L for males and < 7.0 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
Sustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment).	—

Secondary

Measure	Time frame
Early viral kinetics vs outcome immunological parameters during treatment (correlation with outcome) liver fibrosis before and after Rx.	—

Contacts

Public ContactHuub C. Gelderblom

DDMRI, Level II, room 212 719 Umbilo Road Durban 4001

gelderblom@ukzn.ac.za+27-31-2604072

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)