Retreatment of chronic hepatitis C patients with pegylated interferon (IFN), ribavirin and amantadine; a pilot study to establish if initial drop in viral load is predictive for sustained virological response

Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)0 sites100 target enrollmentFebruary 14, 2006

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)
Enrollment: 100
Status: Completed
Last Updated: 5 years ago

Registry

who.int

Start Date

February 14, 2006

End Date

January 1, 2007

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)

•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

•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 \<32 g/l, PTT prolonged \>4 s, bilirubin \> 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 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