A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive 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: Entecavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00614471

ML20742

Details and patient eligibility

About

This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.

Enrollment

219 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, 18-65 years of age;
HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
absence of cirrhosis confirmed by liver biopsy in previous 12 months.

Exclusion criteria

previous treatment for chronic hepatitis B within previous 6 months;
antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.