A phase IV, 2x2 factorial, double blind study of 24 versus 48 weeks and 90 versus 180 mcg doses of pegylated interferon alfa 2a 40KD (PEG IFN, Ro 25-8310) in adult patients with HBeAg positive chronic hepatitis B. - NEPTUNE

F.Hoffmann-La Roche Ltd0 sites524 target enrollmentJanuary 11, 2007

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2007

End Date

April 16, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Age \>\= 18 years
•Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA (patients must have \> 500,000 copies/ml (100,000 IU/ml) as measured by PCR) and anti HBs negative
•Elevated serum ALT \> ULN but \<\= 10 x ULN as determined by two abnormal values taken \>\= 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained \<\= 35 days prior to the first dose.
•A liver biopsy obtained within the past 2 years (and more than 6 months after the end of any previous therapy for hepatitis B) demonstrating liver disease consistent with chronic hepatitis B. Patients with cirrhosis or bridging fibrosis on liver biopsy must also have a liver imaging study to rule out hepatic carcinoma.
•Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24\-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes

•Patients must not have received antiviral therapy for their chronic hepatitis B within the previous 6 months. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had a limited (\<\= 7 day) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
•Positive test at screening for HAV IgM Ab, HCV\-RNA or HCVAb, HDV Ab or HIV Ab.
•Serum concentrations of ceruloplasmin or alfa1\-antitrypsin consistent with an increased risk of metabolic liver disease.
•Any evidence of decompensated liver disease (Childs B\-C, Appendix 2\)
•History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
•Women with ongoing pregnancy or who are breast feeding.
•Neutrophil count \< 1500 cells/mm3or platelet count \< 90,000 cells/mm3\.
•Serum creatinine level \> 1\.5 times the upper limit of normal at screening.
•Evidence of alcohol and/or drug abuse within one year of entry.
•History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.