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

ISRCTN ISRCTN59358441
DOI https://doi.org/10.1186/ISRCTN59358441
Secondary identifying numbers NTR560
Submission date
04/04/2006
Registration date
04/04/2006
Last edited
17/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Huub Gelderblom
Scientific

Academic Medical Center (AMC)
Department of Gastroenterology
AMC Liver Center
C2-331
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5668748
Email h.c.gelderblom@amc.nl

Study information

Study designMulticentre randomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymVKF3
Study objectivesIn 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(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedHepatitis C virus (HCV)
InterventionAll 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 typeOther
Primary outcome measureSustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment).
Secondary outcome measures1. Early viral kinetics versus outcome
2. Immunological parameters during treatment (correlation with outcome)
3. Liver fibrosis before and after Rx
Overall study start date01/07/2002
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants58
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/07/2002
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

Department of Gastroenterology
AMC Liver Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (Netherlands)

No information available

Schering-Plough (Netherlands)
Private sector organisation / For-profit companies (industry)
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/07/2009 Yes No