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Interferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4.


- candidate number1914
- NTR NumberNTR560
- ISRCTNISRCTN59358441
- Date ISRCTN created4-apr-2006
- date ISRCTN requested24-mrt-2006
- Date Registered NTR4-jan-2006
- Secondary IDsN/A 
- Public TitleInterferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4.
- Scientific TitleInterferon induction followed by PEG-interferon combined with ribavirin and amantadine for treatment of naive chronic hepatitis C patients with genotype 1 or 4; Pilot study to establish if initial drop in viral load is predictive for sustained virological response.
- ACRONYMVKF3
- hypothesisIn 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 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.
- Healt Condition(s) or Problem(s) studiedHepatitis C
- 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.
- 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 HIV antibody positive or who are unwilling to have these tests done;
3. Patients with decompensated cirrhosis (e.g. albumin < 32g/L, PTT prolonged > 4 s, bilirubin 2x > upper limit of normal, AT III < 60%, ascites, GI bleeding, encephalopathy);
4. Patients with a history of i.v. 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 < 3.0x10E9/L, granulocytes < 1.5x10E9/L, platelets < 100x10E9/L neutrophil count < 1.5x10E9 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 CNS dysfunction;
12. Patients with any condition, that in the opinion of the investigator, might interfere with the outcome of the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2002
- planned closingdate1-jan-2007
- Target number of participants58
- InterventionsAll patients will be treated for 24 or 48 weeks. Patients who achieve a 3log 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.
- Primary outcomeSustained virological response (HCV RNA undetectable 24 weeks after cessation of treatment).
- Secondary outcomeEarly viral kinetics vs outcome immunological parameters during treatment (correlation with outcome) liver fibrosis before and after Rx.
- TimepointsN/A
- Trial web siteamc.levercentrum.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. MPH. Huub C. Gelderblom
- CONTACT for SCIENTIFIC QUERIESMD. H.W. Reesink
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology, AMC Liver Center
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Schering-Plough
- PublicationsN/A
- Brief summaryIn 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 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.
- Main changes (audit trail)
- RECORD4-jan-2006 - 27-aug-2010


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