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)

Roche

Status and phase

Completed

Phase 4

Conditions

Hepatitis C, Chronic

Treatments

Drug: peginterferon alfa-2a

Drug: ribavirin [Copegus]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01447420

ML25592

Details and patient eligibility

About

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 with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Enrollment

129 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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