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Ribavirin, Its Dosing Regime (Ribados)

This study is currently recruiting participants.
Verified July 2011 by Maastricht University Medical Center
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00484328
First received: June 7, 2007
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

June 7, 2007
July 19, 2011
July 2007
December 2011   (final data collection date for primary outcome measure)
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph [ Time Frame: within 24 weeks after enrollment ] [ Designated as safety issue: No ]
The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph [ Time Frame: within 24 weeks after enrollment ]
Complete list of historical versions of study NCT00484328 on ClinicalTrials.gov Archive Site
  • The tolerability of the treatment at different dosage regimes of ribavirin [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The antioxidant capacity in plasma and erythrocytes at different dosing regimes [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The effect of ribavirin on the hemolysis [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
  • The tolerability of the treatment at different dosage regimes of ribavirin [ Time Frame: 24 weeks of treatment ]
  • The antioxidant capacity in plasma and erythrocytes at different dosing regimes [ Time Frame: 24 weeks of treatment ]
  • The effect of ribavirin on the hemolysis [ Time Frame: 24 weeks of treatment ]
  • The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes [ Time Frame: 24 weeks of treatment ]
Not Provided
Not Provided
 
Ribavirin, Its Dosing Regime
Ribavirin, Its Dosing Regime

The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.

The pharmacokinetics of ribavirin at different dosage regimes is investigated.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
Drug: Ribavirin
different dosing regimes of Ribavirin
  • Experimental: 1
    Intervention: Drug: Ribavirin
  • Experimental: 2
    Intervention: Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • anti-HCV positivity > 6 months
  • Positive HCV-RNA genotype 1 or 4
  • Liver biopsy within one year before the start of therapy
  • Intention to be treated and participate treatment
  • body weight at or above 75 kg

Exclusion Criteria:

  • HIV positive
Both
18 Years and older
No
Contact: Jiska M Balk, PhD +31433882106 jiska.balk@farmaco.unimaas.nl
Netherlands
 
NCT00484328
MEC-07-3-007
No
Prof. A.Bast, Maastricht University
Maastricht University Medical Center
Roche Pharma AG
Principal Investigator: Aalt Bast, Prof.Dr. Maastricht University
Maastricht University Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP