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

Not Applicable

Completed

• Conditions: Hepatitis C; Infections and Infestations

• Registration Number: ISRCTN81536220
• Lead Sponsor: Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center (The Netherlands)

Brief Summary

2008 results in https://pubmed.ncbi.nlm.nih.gov/18584525/ (added 25/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-14
• Study Completion: 2007-01-01
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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 <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
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