Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Information source: UMC Utrecht
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: Amantadine (Drug)
Phase: Phase 3
Sponsored by: UMC Utrecht
Official(s) and/or principal investigator(s):
Karel v. Erpecum, MD, PhD, Principal Investigator, Affiliation: UMC Utrecht, dept. Gastroenterology
Melvin Samsom, MD, PhD, Principal Investigator, Affiliation: UMC Utrecht, dept gastroenterology
* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in
patients with chronic hepatitis C
Official title: Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Response rate at end of treatment and end of follow-up (sustained response rate)
The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in
previously untreated patients suffering from chronic hepatitis C comparing double therapy,
consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A«) and ribavirin (Rebetol«), with
triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52
weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included.
Patients will be stratified before randomisation according to genotype (1 versus non-1).
Viral load will not be a discriminating factor.
The aim is to investigate the efficacy of the adjunct amantadine to the currently used
combination therapy with interferon alpha and ribavirin.
Minimum age: 18 Years.
Maximum age: N/A.
- Anti-HCV positivity >6 months
- 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
- Age < 18 years
- 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 ╬╝mol/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
- Other serious disease (e. g. malignancy, uncontrolled myocardial disease or severe
- 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
Locations and Contacts
UMC Utrecht, Utrecht 3508 GA, Netherlands
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.
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.
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.
Starting date: February 2000
Ending date: January 2007
Last updated: September 1, 2005