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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)

NCT01429792

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis C, Chronic

Interventions: peginterferon alfa-2a [Pegasys], ribavirin [Copegus]

Countries: Israel

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 (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (26)

Afula, Israel
Ashdod, Israel
Ashkelon, Israel
Bat Yam, Israel
Beersheba, Israel
Beersheba, Israel
Haifa, Israel
Haifa, Israel
Haifa, Israel
Holon, Israel
Jerusalem, Israel
Jerusalem, Israel
Kfar Saba, Israel
Nahariya, Israel
Nazareth, Israel
Petah Tikva, Israel
Petah Tikva, Israel
Ramat Gan, Israel
Rehovot, Israel
Rishon LeZiyyon, Israel
Safed, Israel
Tel Aviv, Israel
Tel Aviv, Israel
Tel Aviv, Israel
Tiberias, Israel
Ẕerifin, Israel