High-dose Ribavirin in Treatment of Chronic Hepatitis C Genotype 1 or 4
NCT00662220 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2014-07-14
Summary
Optimal ribavirin dosages are essential in achieving SVR (sustained virological response). Several studies have shown higher SVR rates in patients receiving higher doses of ribavirin. Therefore we propose a randomized controlled open label multicenter trial to investigate wether high (25-29mg/kg) dose ribavirin can improve outcome in patients in infected with hepatitis C virus genotype 1 or 4 compared to standard dose (12-15mg/kg).
Conditions
- Chronic Hepatitis C
Interventions
- DRUG
-
ribavirin
25-29 mg/kg/day
- DRUG
-
ribavirin
12-15 mg/kg/day
Sponsors & Collaborators
- collaborator INDUSTRY
-
Foundation for Liver Research
lead OTHER
Principal Investigators
-
R J de Knegt, MD PhD · Erasmus Medical Center
-
J PH Drenth, MD PhD · St Radboud Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-11-30
Countries
- Netherlands
Study Locations
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