A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and 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: entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940485

ML22265

Details and patient eligibility

About

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >=18 and </= 65 years of age
• HBeAg positive chronic hepatitis B
• Pre-treatment with entecavir for 9-36 months

Exclusion criteria

• Antiviral, antineoplastic or immunomodulatory treatment
• Co-infection with active hepatitis A, C or D, or HIV
• Evidence of decompensated liver disease
• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Peginterferon alfa-2a + entecavir

Experimental group

Description:

Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.

Treatment:

Drug: entecavir

Drug: peginterferon alfa-2a [Pegasys]

Drug: entecavir

Entecavir

Active Comparator group

Description:

Participants received entecavir 0.5 mg orally once daily for 48 weeks.

Treatment:

Drug: entecavir

Drug: entecavir