A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

NCT ID: NCT00144469

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2005-03-31

Brief Summary

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.

Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Detailed Description

Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.

All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

peginterferon alfa-2a

Intervention Type: DRUG

rivavirin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
• elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
• liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria

• Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
• leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
• thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
• anemia (less than 12 g hemoglobin per deciliter )
• hepatitis B co-infection
• decompensated liver disease
• organ transplant
• creatinine clearance less than 50 milliliters per minute
• poorly controlled psychiatric disease
• poorly controlled diabetes
• malignant neoplastic disease
• severe cardiac or chronic pulmonary disease
• immunologically mediated disease
• retinopathy.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chugai Pharmaceutical

Principal Investigators

Hirokazu Furuta

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

JV15725

Identifier Type: -

Identifier Source: org_study_id