Working… Menu
Trial record 86 of 396 for:    IFNA2 AND RBV AND sustained

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146016
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 5, 2005
Information provided by:
UMC Utrecht

Brief Summary:
* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Amantadine Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 390 participants
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
Study Start Date : February 2000
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146016

Layout table for location information
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Layout table for investigator information
Principal Investigator: Karel v. Erpecum, MD, PhD UMC Utrecht, dept. Gastroenterology
Principal Investigator: Melvin Samsom, MD, PhD UMC Utrecht, dept gastroenterology

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00146016     History of Changes
Other Study ID Numbers: CIRA-study
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 5, 2005
Last Verified: September 2005
Keywords provided by UMC Utrecht:
Chronic Hepatitis C
Triple therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, 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