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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01179594
First Posted: August 11, 2010
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
August 10, 2010
August 11, 2010
February 17, 2017
September 18, 2010
November 2014   (Final data collection date for primary outcome measure)
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml) [ Time Frame: 48 weeks after the end of treatment ]
Same as current
Complete list of historical versions of study NCT01179594 on ClinicalTrials.gov Archive Site
Correlation early HBsAg response - response end of treatment/follow-up [ Time Frame: every 6 weeks up to week 48, every 12 weeks therafter ]
Same as current
Not Provided
Not Provided
 
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: entecavir
    0.5 mg orally daily, 24 weeks (weeks 12-36)
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc weekly, 48 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc weekly, 96 weeks
  • Drug: placebo
    orally daily, 24 weeks (weeks 12-36)
  • Placebo Comparator: A
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: placebo
  • Experimental: B
    Interventions:
    • Drug: entecavir
    • Drug: peginterferon alfa-2a [Pegasys]
  • Placebo Comparator: C
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: placebo
  • Experimental: D
    Interventions:
    • Drug: entecavir
    • Drug: peginterferon alfa-2a [Pegasys]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Brazil,   Germany,   Greece,   India,   Korea, Republic of,   Thailand,   Turkey
 
NCT01179594
MV22597
2009-017602-36
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP