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)

NCT ID: NCT01447420

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-11-30

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 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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon Alfa-2a Plus Ribavirin

Group Type: EXPERIMENTAL

peginterferon alfa-2a

Intervention Type: DRUG

180 mcg sc weekly, 48 weeks

ribavirin [Copegus]

Intervention Type: DRUG

1'000 or 1'200 mg orally daily, 48 weeks

Interventions

peginterferon alfa-2a

180 mcg sc weekly, 48 weeks

Intervention Type: DRUG

ribavirin [Copegus]

1'000 or 1'200 mg orally daily, 48 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Vitória, Espírito Santo, Brazil

Salvador, Estado de Bahia, Brazil

Juiz de Fora, Minas Gerais, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Joinville, Santa Catarina, Brazil

Sao Jose Do Rio Preto, Santa Catarina, Brazil

Botucatu, São Paulo, Brazil

Campinas, São Paulo, Brazil

Campinas, São Paulo, Brazil

Santos, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Sorocaba, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ML25592

Identifier Type: -

Identifier Source: org_study_id