Ribavirin, Its Dosing Regime

Hepatitis C Clinical Trial

— Ribados  

Official title:

Ribavirin, Its Dosing Regime

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484328
• Other study ID #: MEC-07-3-007
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2007
• Last updated: January 5, 2018
• Start date: July 2007
• Est. completion date: December 2012

Study information

• Verified date: July 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Ribavirin
different dosing regimes of Ribavirin

Locations

Country	Name	City	State
Netherlands	University of Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Roche Pharma AG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetics of ribavirin at different dosage regimes, measured by the area under the curve of the concentration-time graph		within 24 weeks after enrollment
Secondary	The tolerability of the treatment at different dosage regimes of ribavirin		24 weeks of treatment
Secondary	The antioxidant capacity in plasma and erythrocytes at different dosing regimes		24 weeks of treatment
Secondary	The effect of ribavirin on the hemolysis		24 weeks of treatment
Secondary	The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes		24 weeks of treatment