Status:
COMPLETED
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-69 years
Phase:
PHASE4
Brief Summary
This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients w...
Eligibility Criteria
Inclusion
- Adult patients, \>/=18 and \<70 years of age at initiation of treatment
- Body weight between 50 kg and 125 kg at baseline
- Chronic hepatitis C, genotype 1
- Chronic liver disease consistent with HCV infection
- Compensated liver disease (Child-Pugh Grade A)
Exclusion
- Pregnant or lactating women, and male partners of pregnant women
- Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
- Previous treatment with interferon or ribavirin
- Positive for hepatitis A, hepatitis B or HIV infection
- History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
- Decompensated liver disease and/or liver disease Child-Pugh classification \>6
- Hepatocellular carcinoma
- History or evidence of esophageal bleeding
- Hemoglobinopathy, or any other cause for possible hemolysis
- Hb \<11 g/dL in women, \<12 g/L in males
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01447420
Start Date
February 1 2011
End Date
November 1 2012
Last Update
July 25 2016
Active Locations (15)
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1
Vitória, Espírito Santo, Brazil, 29043-260
2
Salvador, Estado de Bahia, Brazil, 41110-170
3
Juiz de Fora, Minas Gerais, Brazil, 36038-330
4
Rio de Janeiro, Rio de Janeiro, Brazil, 20020-022