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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00304551

Enrollment

180

Registered

2006-03-20

Start date

2006-06-30

Completion date

2010-06-30

Last updated

2010-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C, Liver Cirrhosis

Keywords

CHC with compensated LC

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.

Interventions

DRUGpeginterferon alfa-2a 180μg

180μg（s.c.）/week for 48 weeks

DRUGpeginterferon alfa-2a 90μg

90μg(s.c.)/week for 48 weeks

DRUGribavirin

600, 800, or 1,000 mg X 2(p.o.)/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026