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CompletedNCT00484328RibadosUpdated Jan 9, 2018

Ribavirin, Its Dosing Regime

A Phase 4 interventional study of Ribavirin in Hepatitis C, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis C

Keywords

  • hepatitis C
  • Ribavirin
  • Dosage
  • Pharmacokinetics
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 15 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • HIV positive
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    Drug: Ribavirin

  • Experimental
    2

    Drug: Ribavirin

Interventions

  • DrugRibavirin

    different dosing regimes of Ribavirin

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of Maastricht
    Maastricht, 6229 ER, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00484328
Lead sponsor
Maastricht University Medical Center
Collaborators
Roche Pharma AG
First posted
Jun 8, 2007
Start date
Jul 2007
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jan 9, 2018

Study contacts

Aalt Bast, Prof.Dr.
principal investigator · Maastricht University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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