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OpenTrials
Completed

NCT Number: NCT00484328

Ribavirin, Its Dosing Regime

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maastricht

Maastricht, 6229 ER, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ribavirin

Drug

different dosing regimes of Ribavirin

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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Roche Pharma AG

Registry information

Acronym: Ribados

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2007
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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