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

Completed

• Conditions: Infections and Infestations; Hepatitis C virus (HCV); Chronic viral hepatitis

• Registration Number: ISRCTN59358441
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 58

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

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 human immunodeficiency virus (HIV) antibody positive or who are unwilling to have these tests done
3. Patients with decompensated cirrhosis (e.g. albumin <32 g/l, PTT prolonged >4 s, bilirubin 2 x upper limit of normal, AT III <60%, ascites, gastrointestinal [GI] bleeding, encephalopathy)
4. Patients with a history of intravenous (iv) drug use within 6 months prior to entry
5. Patients with any clinically significant systemic disease other than liver disease (e.g. malignant disease, congestive heart failure, uncontrolled diabetes mellitus, renal failure (serum creatinine >181 µmol/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 <1.5 x 10^9/l, platelets <100 x 10^9/l, neutrophil count <1.5 x 10^9 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment).

Secondary Outcome Measures

Name	Time	Method
1. Early viral kinetics versus outcome<br>2. Immunological parameters during treatment (correlation with outcome)<br>3. Liver fibrosis before and after Rx