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 |
| Protocol serial number | NTR560 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funders | Academic Medical Centre (AMC) (Netherlands), Schering-Plough (Netherlands) |
- 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
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 |
|---|---|
| h.c.gelderblom@amc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | VKF3 |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Sustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment). |
| Key secondary outcome measure(s) |
1. Early viral kinetics versus outcome |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 58 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
