Multicenter Study Evaluating 12 Versus 24 Weeks Therapy With Peginterferon and Ribavirin for Hepatitis C Virus (HCV) Genotype 2 or 3

NORDynamIC Study Group

Status and phase

Completed

Phase 4

Conditions

Hepatitis C Virus

Treatments

Drug: Peginterferon alfa-2a 40KD and Ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00143000

Ethical Committee nr. Ö 763/03

Swedish MPA nr. 151:2004/3458

Details and patient eligibility

About

The primary objective of the study is to demonstrate that the efficacy of peginterferon alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic hepatitis C virus infection genotype 2 or 3 given for 12 weeks is non-inferior to 24 weeks.

Full description

Primary Objective of the Study: To demonstrate that the efficacy of peginterferon alfa-2a 40KD combination therapy with ribavirin in interferon naïve patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 given for 12 weeks is non-inferior to 24 weeks.

Enrollment

392 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients ≥18 years of age
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Serum HCV-RNA quantifiable at >600 IU/mL by the Roche AMPLICOR HCV MONITOR® Test, v2.0.
HCV genotype 2 or 3 infection confirmed within the past 2 years preceding the initiation of test drug dosing.
Elevated serum ALT activity documented on at least one occasion within the past 12 months preceding the initiation of test drug dosing.
Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 2 years) as judged by a local pathologist.
Compensated liver disease (Child-Pugh Grade A clinical classification)
Patients with 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

Exclusion criteria

Women with ongoing pregnancy or breast feeding
IFN or ribavirin therapy at any previous time
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 <90,000 cells/mm3 at screening
Serum creatinine level >2 mg/dl (>124 µmol/L) or creatinine clearance <50 ml/minute at screening
Severe psychiatric disease, especially depression, as judged by the treating physician.
History of a severe seizure disorder or current anticonvulsant use
History of immunologically mediated disease, severe chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range)
Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
Evidence of drug abuse (including excessive alcohol consumption) in accordance with local therapeutic traditions.
Inability or unwillingness to provide informed consent or abide by the requirements of the study
Male partners of women who are pregnant
Ηemoglobin <11.3 g/dL (<7.0 mmol/L) in women or <12.9 g/dL (<8.0 mmol/L) in men at screening.
Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated