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Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

This study has been completed.
Information provided by:
UMC Utrecht Identifier:
First received: September 1, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

Condition Intervention Phase
Chronic Hepatitis C Drug: Amantadine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Resource links provided by NLM:

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Response rate at end of treatment and end of follow-up (sustained response rate)

Estimated Enrollment: 390
Study Start Date: February 2000
Estimated Study Completion Date: January 2007
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00146016

UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: Karel v. Erpecum, MD, PhD UMC Utrecht, dept. Gastroenterology
Principal Investigator: Melvin Samsom, MD, PhD UMC Utrecht, dept gastroenterology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00146016     History of Changes
Other Study ID Numbers: CIRA-study
Study First Received: September 1, 2005
Last Updated: September 1, 2005

Keywords provided by UMC Utrecht:
Chronic Hepatitis C
Triple therapy

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Analgesics, Non-Narcotic
Analgesics processed this record on September 19, 2017