Status:
COMPLETED
Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
Lead Sponsor:
University College London Hospitals
Conditions:
Chronic Hepatitis C, HCV Genotype 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated bet...
Detailed Description
Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interfero...
Eligibility Criteria
Inclusion
- Age 18 - 65
- HCV RNA positive
- HCV genotype 1
- Histologically proven chronic hepatitis
- No previous antiviral treatment
Exclusion
- Liver histology showing cirrhosis
- Decompensated liver function
- WCC \< 1500/mm3 or platelet count \<90,000/mm3
- Co-infection with HIV or HBV/HAV
- Alcohol intake greater than 40 units/week
- Current intravenous drug dependence
- Pregnancy or breast feeding of infants
- Inadequate contraception
- Neuropsychiatric disorder
- Neoplastic disease
- Other significant medical problems
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00152581
Start Date
April 1 2002
Last Update
December 1 2005
Active Locations (1)
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1
Hepatitis Clinic
University College London Hospital, London, United Kingdom, WC1E 6HX