Contact information
Type
Scientific
Primary contact
Dr Huub Gelderblom
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Gastroenterology
AMC Liver Center
C2-331
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5668748
h.c.gelderblom@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR560
Study information
Scientific title
Acronym
VKF3
Study hypothesis
In this study previously untreated patients with chronic hepatitis C will receive high induction dose of IFN combined with Ribavirin and Amantadine for 6 weeks. Subsequently IFN is replaced by Peg IFN combined with Ribavirin and Amantadine.
The aim of the study is to determine with the above treatment schedule, if a higher sustained virological response (SVR) rate can be achieved in patients with genotype 1 or 4 and to establish if the drop in viral load in the first 4 weeks of treatment is predictive for SVR.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hepatitis C virus (HCV)
Intervention
All patients will be treated for 24 or 48 weeks. Patients who achieve a 3 log drop in viral load after 4 weeks of treatment will be randomized to stop treatment early after 24 weeks or continue to 48 weeks. Patients who do not achieve a 3 log drop after 4 weeks of treatment will be treated for 48 weeks. Patients who are HCV RNA positive at week 24 will stop treatment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Sustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment).
Secondary outcome measures
1. Early viral kinetics versus outcome
2. Immunological parameters during treatment (correlation with outcome)
3. Liver fibrosis before and after Rx
Overall trial start date
01/07/2002
Overall trial end date
01/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
58
Participant 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
Recruitment start date
01/07/2002
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Schering-Plough (Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19193032