Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
NCT ID: NCT00146016
Last Updated: 2005-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2000-02-29
2007-01-31
Brief Summary
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Detailed Description
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The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Amantadine
Eligibility Criteria
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Inclusion Criteria
* ALT and/or AST elevation on at least once in the previous 6 months
* Positive HCV-RNA
* Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary
* Intention to be treated and participate treatment
* Obtained written informed consent
Exclusion Criteria
* Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
* Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
* Life expectancy \< 1 year
* Child Pugh B or C (Appendix III)
* Creatinine \> 150 μmol/L or \> 1.70 mg/dl
* Haemoglobulin \< 6.5 mmol/l or \< 10.5 g/dl
* White blood cell count \< 2,5 x 109/L, neutrophil \< 1,5 x 109/L
* Platelet count \< 70 x 109/L
* HIV positivity
* Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
* Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
* Active uncontrolled psychiatric disorders and suicidal leanings
* Patients with a history of uncontrolled seizure or other significant CNS dysfunction
* Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Principal Investigators
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Karel v. Erpecum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht, dept. Gastroenterology
Melvin Samsom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht, dept gastroenterology
Locations
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UMC Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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Berg T, Kronenberger B, Hinrichsen H, Gerlach T, Buggisch P, Herrmann E, Spengler U, Goeser T, Nasser S, Wursthorn K, Pape GR, Hopf U, Zeuzem S. Triple therapy with amantadine in treatment-naive patients with chronic hepatitis C: a placebo-controlled trial. Hepatology. 2003 Jun;37(6):1359-67. doi: 10.1053/jhep.2003.50219.
Brillanti S, Levantesi F, Masi L, Foli M, Bolondi L. Triple antiviral therapy as a new option for patients with interferon nonresponsive chronic hepatitis C. Hepatology. 2000 Sep;32(3):630-4. doi: 10.1053/jhep.2000.16235.
Younossi ZM, McCullough AC, Barnes DS, Post A, Ong JP, O'Shea R, Martin LM, Bringman D, Farmer D, Levinthal G, Mullen KD, Carey WD, Tavill AS, Ferguson R, Gramlich T. Pegylated interferon alpha-2b, ribavirin and amantadine for chronic hepatitis C. Dig Dis Sci. 2005 May;50(5):970-5. doi: 10.1007/s10620-005-2673-y.
Van Vlerken LG, Van Soest H, Janssen MP, Boland GJ, Drenth JP, Burger DM, Siersema PD, Van Erpecum KJ. Suboptimal endogenous erythropoietin response in chronic hepatitis C patients during ribavirin and PEG interferon treatment. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1308-15. doi: 10.1097/MEG.0b013e32833e784d.
Other Identifiers
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CIRA-study
Identifier Type: -
Identifier Source: org_study_id