A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

Roche

Status and phase

Completed

Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: peginterferon alfa-2a [Pegasys]

Drug: Adefovir

Drug: Placebo

Drug: Entecavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00922207

ML21827

Details and patient eligibility

About

This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Enrollment

280 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, 18-65 years of age;
HBeAg+ve for >=3 months;
positive serum HBV DNA within 3 months prior to entry;
patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
>=3 months treatment-free interval from nucleotide analogues.

Exclusion criteria

evidence of decompensated liver disease;
history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
co-infection with active hepatitis A,C or D, or HIV.