Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients

Summary

Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the world's population. The current standard of therapy is pegylated interferon and ribavirin, reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week course of combination therapy has achieved a higher successful rate that a 24 weeks course of therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has comparable or even better response to a 48 week course of therapy in Western countries. Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.

Conditions

• Hepatitis C, Chronic

Interventions

DRUG

Pegylated interferon alfa-2a plus ribavirin

Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks

DRUG

Pegylated interferon alfa-2a plus ribavirin

Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Jia-Horng Kao, MD, PhD · National Taiwan University Hospital

• Ding-Shinn Chen, MD · National Taiwan University Hospital

• Ming-Yang Lai, MD, PhD · National Taiwan University Hospital

• Pei-Jer Chen, MD, PhD · National Taiwan University Hospital

• Chun-Jen Liu, MD, PhD · National Taiwan University Hospital

• Chen-Hua Liu, MD · National Taiwan University Hospital

• Shih-Jer Hsu, MD · National Taiwan University Hosptial, Yun-Lin Branch

• Chih-Lin Lin, MD · Ren-Ai Branch, Taipei City Hospital

• Cheng-Chao Liang, MD · Far Eastern Memorial Hospital

• Ching-Sheng Hsu, MD · Buddhist Tzu Chi General Hospital

• Sheng-Shun Yang, MD · Taichung Veterans General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2008-06-30

Completion

2008-07-31

Countries

• Taiwan

Study Locations