Ribavirin, Its Dosing Regime (Ribados)

January 5, 2018 updated by: Maastricht University Medical Center
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 ER
        • University of Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Ribavirin
different dosing regimes of Ribavirin
Experimental: 2
Drug: Ribavirin
different dosing regimes of Ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 24 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
The tolerability of the treatment at different dosage regimes of ribavirin
Time Frame: 24 weeks of treatment
24 weeks of treatment
The antioxidant capacity in plasma and erythrocytes at different dosing regimes
Time Frame: 24 weeks of treatment
24 weeks of treatment
The effect of ribavirin on the hemolysis
Time Frame: 24 weeks of treatment
24 weeks of treatment
The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes
Time Frame: 24 weeks of treatment
24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Aalt Bast, Prof.Dr., Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-07-3-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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