Status:
COMPLETED
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
Exclusion
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- Therapy with antineoplastic treatment \</= 6 months prior to study day
- Diabetes mellitus in subjects receiving an insulin therapy
- Evidence of severe retinopathy
- Pregnant or breast-feeding women, and male partners of women who are pregnant
Key Trial Info
Start Date :
September 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2013
Estimated Enrollment :
1013 Patients enrolled
Trial Details
Trial ID
NCT01429792
Start Date
September 25 2008
End Date
June 10 2013
Last Update
October 23 2018
Active Locations (26)
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1
Haemek Hospital; Gastroenterology
Afula, Israel, 18101
2
Clalit City Ashdod MC; Liver Clinic
Ashdod, Israel, 77444
3
Barzilai MC; Gastroenterology
Ashkelon, Israel, 78278
4
Batyamon; Liver Unit
Bat Yam, Israel