Recruitment

Recruitment Status
Completed
Estimated Enrollment
750

Inclusion Criterias

All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Male and female patients *18 years of age
Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
...
All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Male and female patients *18 years of age
Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Compensated liver disease (Child-Pugh Grade A clinical classification)
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
Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Detectable serum HCV-RNA and HCV viral genotype 1

Exclusion Criterias

History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
History or other 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 bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
History or other 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)
Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
Any investigational drug *6 weeks prior to the first dose of study drug
Signs or symptoms of hepatocellular carcinoma
Women with ongoing pregnancy or breast feeding
Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug

Summary

Conditions
Hepatitis C
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The aims of the present study are: To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defi...

The aims of the present study are: To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment) To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients with PCR-seropositive of HCV RNA at week 12

Inclusion Criterias

All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Male and female patients *18 years of age
Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
...
All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Male and female patients *18 years of age
Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Compensated liver disease (Child-Pugh Grade A clinical classification)
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
Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Detectable serum HCV-RNA and HCV viral genotype 1

Exclusion Criterias

History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
History or other 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 bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
History or other 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)
Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
Any investigational drug *6 weeks prior to the first dose of study drug
Signs or symptoms of hepatocellular carcinoma
Women with ongoing pregnancy or breast feeding
Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug

Locations

Kaohsiung
Kaohsiung

Tracking Information

NCT #
NCT01937728
Collaborators
Not Provided
Investigators
  • Principal Investigator: Chia-Yen Dai, M.D., PhD. Kaohsiung Medical University
  • Chia-Yen Dai, M.D., PhD. Kaohsiung Medical University