Hepatitis C
Conditions
Keywords
Hepatitis C, Genotype 1, Peg interferon, alfa 1a, Ribavirin
Brief summary
The purposes of this study are: 1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL 2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12
Detailed description
The aims of the present study are: 1. 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) 2. 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
Interventions
DRUGA: Peg-interferon alpha-2a & Ribavirin
Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA \< 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
DRUGB: Peg-interferon alpha-2a & Ribavirin
Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1. Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.
DRUGC: Peg-interferon alpha-2a & Ribavirin
Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1. Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
DRUGD: Peg-interferon alpha-2a & Ribavirin
Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
DRUGE: Peg-interferon alpha-2a & Ribavirin
Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1. Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
DRUGF: Peg-interferon alpha-2a & Ribavirin
Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1. Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients \*18 years of age * 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 * 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 * 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
Exclusion criteria
* 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 * Any investigational drug \*6 weeks prior to the first dose of study drug * 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) * Signs or symptoms of hepatocellular carcinoma * History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease * Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 24-week off-treatment period | Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 24-week off-treatment period | adverse event rate and profile |
Countries
Taiwan
Outcome results
None listed