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

Academic Medical Centre (AMC) (Netherlands)0 sites58 target enrollmentApril 4, 2006

Overview

No summary available.

Registry

who.int

Start Date

April 4, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sponsor

Academic Medical Centre (AMC) (Netherlands)

•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

•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