A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.

Roche

Status and phase: Withdrawn; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: placebo; Drug: entecavir; Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01179594

2009-017602-36

MV22597

Details and patient eligibility

About

This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >/= 18 years of age
• chronic hepatitis B for >/= 6 months
• HBeAg negative at screening
• adequate renal function

Exclusion criteria

• antiviral therapy for chronic hepatitis B within the previous 6 months
• hepatitis A, C, D or HIV infection
• treatment with systemic acyclovir or famciclovir within the previous 6 months
• decompensated liver disease (Childs B-C)
• history or evidence of a medical condition associated with chronic liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: placebo

Drug: peginterferon alfa-2a [Pegasys]

B

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: entecavir

Drug: peginterferon alfa-2a [Pegasys]

C

Placebo Comparator group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: placebo

Drug: peginterferon alfa-2a [Pegasys]

D

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: entecavir

Drug: peginterferon alfa-2a [Pegasys]