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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Cirrhosis Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

peginterferon alfa-2a 180μg

Intervention Type DRUG

180μg（s.c.）/week for 48 weeks

ribavirin

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

peginterferon alfa-2a 90μg

Intervention Type DRUG

90μg(s.c.)/week for 48 weeks

ribavirin

Intervention Type DRUG

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

3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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peginterferon alfa-2a 180μg

180μg（s.c.）/week for 48 weeks

Intervention Type DRUG

peginterferon alfa-2a 90μg

90μg(s.c.)/week for 48 weeks

Intervention Type DRUG

ribavirin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No