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

This study has been withdrawn prior to enrollment.
(This study was canceled for operational reasons.)
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 10, 2010
Last updated: February 16, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: entecavir
Drug: peginterferon alfa-2a [Pegasys]
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml) [ Time Frame: 48 weeks after the end of treatment ]

Secondary Outcome Measures:
  • Correlation early HBsAg response - response end of treatment/follow-up [ Time Frame: every 6 weeks up to week 48, every 12 weeks therafter ]

Enrollment: 0
Anticipated Study Start Date: September 18, 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: placebo
orally daily, 24 weeks (weeks 12-36)
Experimental: B Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Placebo Comparator: C Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: placebo
orally daily, 24 weeks (weeks 12-36)
Experimental: D Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01179594

Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01179594     History of Changes
Other Study ID Numbers: MV22597
Study First Received: August 10, 2010
Last Updated: February 16, 2017

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017