A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC

Chugai Pharmaceutical8 sites in 1 country180 target enrollmentJune 2006

ConditionsLiver Cirrhosis Chronic Hepatitis C

Interventionspeginterferon alfa-2a 90μg ribavirin peginterferon alfa-2a 180μg

Drugspeginterferon alfa-2a 180μg peginterferon alfa-2a 90μg ribavirin

Overview

Phase: Phase 3
Intervention: peginterferon alfa-2a 90μg
Conditions: Liver Cirrhosis
Sponsor: Chugai Pharmaceutical
Enrollment: 180
Locations: 8
Primary Endpoint: Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.

Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

June 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chugai Pharmaceutical

Eligibility Criteria

Inclusion Criteria

•Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.

Exclusion Criteria

•Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
•Thrombocytopenia (fewer than 75,000 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

Arms & Interventions

2

Intervention: peginterferon alfa-2a 90μg

2

Intervention: ribavirin

1

Intervention: peginterferon alfa-2a 180μg

1

Intervention: ribavirin

Outcomes

Primary Outcomes

Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])

Time Frame: week 24 from the end of treatment

Secondary Outcomes

Biochemical response (normalization of serum alanine aminotransferase activity)(at the end of treatment and week 24 form the end of treatment)
Virological response (HCV-RNA < 50 IU per milliliter)(at the end of treatment and week 24 form the end of treatment)