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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01179594
First received: August 10, 2010
Last updated: January 18, 2011
Last verified: December 2010
History of Changes
  Purpose

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: peginterferon alfa-2a [Pegasys]
Drug: entecavir
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Estimated Study Completion Date: November 2014
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: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
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: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179594

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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01179594     History of Changes
Other Study ID Numbers: MV22597, 2009-017602-36
Study First Received: August 10, 2010
Last Updated: January 18, 2011
Health Authority: Korea: President of Samsung Medical Center

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Interferon-alpha
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013