Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00107653

ML18179

Details and patient eligibility

About

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Enrollment: 569 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients 18-65 years of age
• chronic hepatitis C , genotype 1
• serologic evidence of CHC infection by an antibody test
• chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
• compensated liver disease
• use of 2 forms of contraception during the study in both men and women

Exclusion criteria

• previous interferon or ribavirin therapy
• systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
• decompensated liver disease
• women who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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569 participants in 2 patient groups

Latino

Experimental group

Description:

Participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Drug: Peginterferon alfa-2a

Drug: Ribavirin

Non-Latino White

Experimental group

Description:

Participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Drug: Peginterferon alfa-2a

Drug: Ribavirin