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

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00146016
First received: September 1, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

* 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146016

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00146016     History of Changes
Other Study ID Numbers: CIRA-study
Study First Received: September 1, 2005
Last Updated: September 1, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Chronic Hepatitis C
Amantadine
Triple therapy

Additional relevant MeSH terms:
Hepatitis
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
Interferon-alpha
Amantadine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on September 22, 2014