Ribavirin, Its Dosing Regime (Ribados)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ribavirin, Its Dosing Regime

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ribavirin
different dosing regimes of Ribavirin
Experimental: 2 Drug: Ribavirin
different dosing regimes of Ribavirin

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.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484328

Contacts
Contact: Jiska M Balk, PhD +31433882106 jiska.balk@farmaco.unimaas.nl

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

No publications provided

Responsible Party: Prof. A.Bast, Maastricht University
ClinicalTrials.gov Identifier: NCT00484328     History of Changes
Other Study ID Numbers: MEC-07-3-007
Study First Received: June 7, 2007
Last Updated: July 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on April 17, 2014