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Ribavirin, Its Dosing Regime (Ribados)

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ClinicalTrials.gov Identifier: NCT00484328
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Ribavirin Phase 4

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ribavirin, Its Dosing Regime
Study Start Date : July 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Ribavirin
different dosing regimes of Ribavirin
Experimental: 2 Drug: Ribavirin
different dosing regimes of Ribavirin



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The tolerability of the treatment at different dosage regimes of ribavirin [ Time Frame: 24 weeks of treatment ]
  2. The antioxidant capacity in plasma and erythrocytes at different dosing regimes [ Time Frame: 24 weeks of treatment ]
  3. The effect of ribavirin on the hemolysis [ Time Frame: 24 weeks of treatment ]
  4. The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes [ Time Frame: 24 weeks of treatment ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00484328


Locations
Netherlands
University of Maastricht
Maastricht, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
Roche Pharma AG
Investigators
Principal Investigator: Aalt Bast, Prof.Dr. Maastricht University

Responsible Party: Prof. A.Bast, Maastricht University
ClinicalTrials.gov Identifier: NCT00484328     History of Changes
Other Study ID Numbers: MEC-07-3-007
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: July 2011

Keywords provided by Maastricht University Medical Center:
hepatitis C
Ribavirin
Dosage
Pharmacokinetics

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents