Neoplasms Clinical Trial
Official title:
The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the
treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The
efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its
impact on the outcome in chronic hepatitis C patients concomitant with malignancy other than
hepatocellular carcinoma deserve to be elucidated.
The purposes of this study are:
1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin
combination therapy in chronic hepatitis C patients concomitant with malignancy other
than hepatocellular carcinoma, compare to those without systemic malignancy.
2. To investigate the role of baseline and on-treatment factors on the response to
pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C
patients concomitant with malignancy other than hepatocellular carcinoma.
A prospective, hospital-based study enrolling 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma and other sex- and age-matched 80 chronic hepatitis C patients without malignancy will be conducted. The 40 chronic hepatitis C patients concomitant with malignancy other than hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 80 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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