Ribavirin, Its Dosing Regime (Ribados)
This study is currently recruiting participants.
Verified July 2011 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Collaborator:
Roche Pharma AG
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00484328
First received: June 7, 2007
Last updated: July 19, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: Ribavirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ribavirin, Its Dosing Regime |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The tolerability of the treatment at different dosage regimes of ribavirin [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
- The antioxidant capacity in plasma and erythrocytes at different dosing regimes [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
- The effect of ribavirin on the hemolysis [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
- The pharmacokinetics of ribavirin in erythrocytes in the different dosing regimes [ Time Frame: 24 weeks of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Ribavirin
different dosing regimes of Ribavirin
|
| Experimental: 2 |
Drug: Ribavirin
different dosing regimes of Ribavirin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484328
Contacts
| Contact: Jiska M Balk, PhD | +31433882106 | jiska.balk@farmaco.unimaas.nl |
Locations
| Netherlands | |
| University of Maastricht | Recruiting |
| Maastricht, Netherlands, 6229 ER | |
Sponsors and Collaborators
Maastricht University Medical Center
Roche Pharma AG
Investigators
| Principal Investigator: | Aalt Bast, Prof.Dr. | Maastricht University |
More Information
No publications provided
| Responsible Party: | Prof. A.Bast, Maastricht University |
| ClinicalTrials.gov Identifier: | NCT00484328 History of Changes |
| Other Study ID Numbers: | MEC-07-3-007 |
| Study First Received: | June 7, 2007 |
| Last Updated: | July 19, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
hepatitis C Ribavirin Dosage Pharmacokinetics |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013