An Open-label, Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 weeks pegylated interferon alfa-2a 40 kD (PEGASYS®) Combination Therapy with Ribavirin (Copegus®) in Patients with Chronic Hepatitis C Genotype 2 or 3 Infection who Previously Have Relapsed After a Minimum of 12 Weeks and a Maximum of 24 Weeks of Therapy with pegylated interferon and Ribavirin - RelapC

HUS0 sites100 target enrollmentJanuary 23, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA < 50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.
Sponsor: HUS
Enrollment: 100
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

January 23, 2007

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

HUS

•Male and female patients \= 18 years of age
•Serologic evidence of chronic hepatitis C infection by an anti\-HCV antibody test
•Serum HCV\-RNA \= 15 IU/mL.
•HCV genotype 2 or 3 infection confirmed within the past 6 months preceding the initiation of test drug dosing. The HCV genotype must have been reconfirmed after the termination of the previous treatment period.
•Previous relapse (i.e. HCV\-RNA \< 50 IU/mL at end of previous therapy) after one treatment period with pegylated interferon alfa\-2a or alfa\-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks.
•A minimum of 24 weeks must have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period before the patients can be included in this study.
•Compensated liver disease (Child\-Pugh Grade A clinical classification)
•Patients with suspected cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP \< 100 ng/mL within 2 months of randomization
•Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24\-hour period prior to the first dose of study drug
•All fertile males and females receiving ribavirin must be using effective contraception during treatment and during the 6 months after treatment end

•Women with ongoing pregnancy or breast feeding
•Previous non\-response during treatment (as defined as having detectable HCV RNA \= 50 IU/ml at the end of previous treatment) with pegylated interferon alfa\-2a or alfa\-2b combination therapy with ribavirin for at least 12 weeks and at most 24 weeks.
•Less than 24 weeks have elapsed since the last dose of pegylated interferon or ribavirin in the previous treatment period prior to inclusion in this study.
•Therapy with any systemic anti\-viral, anti\-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \= 6 months prior to the first dose of study drug
•Any investigational drug \= 6 weeks prior to the first dose of study drug.
•HCV genotype 1, 4, 5 or 6 infection.
•Positive test at screening for anti\-HAV IgM Ab, HBsAg, anti\-HBc IgM Ab, anti\-HIV Ab
•Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
•History or other evidence of decompensated liver disease
•Neutrophil count \< 1500 cells/mm3 or platelet count \< 75,000 cells/mm3 at screening