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

A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01179594

Enrollment

Registered

2010-08-11

Start date

2010-09-18

Completion date

2014-11-30

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief summary

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.

Interventions

DRUGentecavir

0.5 mg orally daily, 24 weeks (weeks 12-36)

DRUGpeginterferon alfa-2a [Pegasys]

180 mcg sc weekly, 48 weeks

DRUGplacebo

orally daily, 24 weeks (weeks 12-36)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)	48 weeks after the end of treatment

Secondary

Measure	Time frame
Correlation early HBsAg response - response end of treatment/follow-up	every 6 weeks up to week 48, every 12 weeks therafter

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026