Status:
COMPLETED
High Dose Ribavirin in the Treatment of Chronic Hepatitis C
Lead Sponsor:
University of Bern
Collaborating Sponsors:
Roche Pharma AG
University of Lausanne
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus (HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of patients experience sust...
Detailed Description
Background Prevalence and incidence of chronic hepatitis C (CHC) are rising worldwide. Complications include chronic liver failure and hepatocellular carcinoma, and chronic hepatitis C is a major ind...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male and female patients aged 18-65 years
- Elevated liver enzymes levels
- Compensated liver disease
- Available liver histology confirming METAVIR F2 fibrosis
- Written consent to participation
- Exclusion Criteria
- Age \<18, \>65
- Prior ribavirin treatment
- Intolerance towards ribavirin, PegIFN or erythropoetin
- Pregnancy or breast feeding
- Relevant cardiovascular or pulmonary disease
- Kidney insufficiency (creatinine clearance \<50ml/min)
- Coinfection with HIV or hepatitis B virus
- Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders)
- Alcohol consumption \> 40g/day
- Psychiatric disorders
- Malignancy (except for basalioma)
- Active consumption of illicit drugs
- Participation in another trial shorter than 3 months prior to inclusion
- Lack of consent
Exclusion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00944684
Start Date
November 1 2007
End Date
April 1 2011
Last Update
November 11 2011
Active Locations (5)
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1
Dept of Gastroenterology, University of Basel
Basel, Switzerland, CH-4031
2
Institute of Clinical Pharmacology and Visceral Research, University of Bern
Bern, Switzerland, CH-3010
3
Division of Gastroenterology, University of Lausanne
Lausanne, Switzerland, CH-1011
4
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, CH-9007