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Ribavirin, Its Dosing Regime (Ribados)

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C, Ribavirin, Dosage, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph

Secondary Outcome Measures

The tolerability of the treatment at different dosage regimes of ribavirin

The antioxidant capacity in plasma and erythrocytes at different dosing regimes

The effect of ribavirin on the hemolysis

The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes

Full Information

NCT ID

NCT00484328

First Posted

June 7, 2007

Last Updated

January 5, 2018

Sponsor

Maastricht University Medical Center

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT00484328

Brief Title

Ribavirin, Its Dosing Regime

Acronym

Ribados

Official Title

Ribavirin, Its Dosing Regime

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

hepatitis C, Ribavirin, Dosage, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Description

different dosing regimes of Ribavirin

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

The tolerability of the treatment at different dosage regimes of ribavirin

Time Frame

24 weeks of treatment

Title

The antioxidant capacity in plasma and erythrocytes at different dosing regimes

Time Frame

24 weeks of treatment

Title

The effect of ribavirin on the hemolysis

Time Frame

24 weeks of treatment

Title

The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes

Time Frame

24 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aalt Bast, Prof.Dr.

Organizational Affiliation

Maastricht University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maastricht

City

Maastricht

ZIP/Postal Code

6229 ER

Country

Netherlands

12. IPD Sharing Statement

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