A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

Phase 3

Completed

• Conditions: Liver Cirrhosis; Chronic Hepatitis C
• Interventions: Drug: peginterferon alfa-2a 180μg; Drug: peginterferon alfa-2a 90μg; Drug: ribavirin

• Registration Number: NCT00304551
• Lead Sponsor: Chugai Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-05
• Study First Submitted QC: 2006-03-16
• Study First Posted: 2006-03-20
• Study Start: 2006-06
• Primary Completion: 2009-12
• Status Verified: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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
• Immunologically mediated disease
• Retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	peginterferon alfa-2a 180μg	-
1	ribavirin	-
2	peginterferon alfa-2a 90μg	-
2	ribavirin	-

Primary Outcome Measures

Name	Time	Method
Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])	week 24 from the end of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Tohoku Region; 🇯🇵 Tohoku, Japan

Hokkaido Region; 🇯🇵 Hokkaido, Japan

Kyusyu Region; 🇯🇵 Kyusyu, Japan

Tokai Region; 🇯🇵 Tokai, Japan

Shikoku Region; 🇯🇵 Shikoku, Japan

Kinki Region; 🇯🇵 Kinki, Japan

Kanto Region; 🇯🇵 Kanto, Japan

Chugoku; 🇯🇵 Chugoku, Japan