Pegintron Induction Therapy in HCV Non-Responders

Foundation for Liver Research

Status and phase

Completed

Phase 3

Conditions

Hepatitis C

Treatments

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00363259

HCV01-01

Details and patient eligibility

About

The purpose of this study is to compare the sustained virological response rate at 24 weeks after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination therapy.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

chronic hepatitis C
non-response or relapse to previous interferon therapy with or without ribavirin for at least 3 months at any previous time
detectable serum HCV-RNA
elevated serum ALT activity documented on at least two occasions within the past 12 months, with at least one during the 90 day screening period preceding the initiation of test drug dosing
liver biopsy findings (during screening or within previous 12 months) consistent with active fibrosis (haemophiliacs are excluded from biopsies)
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 and their fertile or potentially fertile partners must be advised to use two forms of effective contraception (combined) during treatment and during the 6 months after end of treatment

Exclusion criteria

history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study
women with ongoing pregnancy or breast feeding
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <3 months prior to the first dose of study drug
any investigational drug <6 weeks prior to the first dose of study drug
positive test at screening for HBsAg, anti-HIV Ab
history or other evidence of bleeding from esophageal varices, ascites, or other conditions consistent with decompensated liver disease (Child-Pugh Grade B or C clinical classification)
Signs or symptoms of hepatocellular carcinoma
history or other strong evidence of a medical condition associated with chronic liver disease other than HCV (e.g., primary hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures
Hb <7.5 mmol/l in women or <8.6 mmol/l in men at screening
any patient with an increased baseline risk for anaemia (e.g. thalassemia, spherocytosis, etc) or for whom anaemia would be medically problematic
neutrophil count <1500 cells/mm3 or platelet count <80,000 cells/mm3 at screening
serum creatinine level >1.5 times the upper limit of normal at screening
history of severe psychiatric disease, especially depression
history of a severe seizure disorder or current anticonvulsant use
history of immunologically mediated disease
history or other evidence of chronic pulmonary disease associated with functional limitation
history of severe allergies
history of symptomatic and/or significant cardiovascular disease
poorly controlled diabetes mellitus
history of major organ transplantation with an existing functional graft
hyper- or hypothyroidism
evidence of severe retinopathy
evidence of drug abuse (including excessive alcohol consumption within one year before study entry