Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

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. Identifier: NCT01243281
Recruitment Status : Unknown
Verified June 2011 by Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : November 18, 2010
Last Update Posted : June 28, 2011
Information provided by:
Chulalongkorn University

November 17, 2010
November 18, 2010
June 28, 2011
March 2011
May 2013   (Final data collection date for primary outcome measure)
To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B [ Time Frame: 24 weeks post treatment ]
Same as current
Complete list of historical versions of study NCT01243281 on Archive Site
To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment [ Time Frame: 24 weeks post treatment ]
Same as current
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Not Provided
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: PEG-IFN and entecavir
The patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule.
Other Names:
  • pegintron
  • baraclude
Active Comparator: drug combination
Intervention: Drug: PEG-IFN and entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women 18 to 65 years of age
  • Patients with HBeAg-negative chronic hepatitis B
  • Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
  • Serum HBV DNA levels ≥ 2,000 IU/mL at screening
  • Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN}
  • No signs or symptoms of advanced liver disease
  • Patient has had a liver biopsy within 1 year of screening

Exclusion Criteria:

  • Patient had previous treatment with IFN, peg-IFN, and/or entecavir
  • Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
  • Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
  • Patients with liver cancer
  • Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
  • Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir
  • Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. Pisit Tangkijvanich, Faculty of Medicine, Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Pisit Tangkijvanich, M.D. Chulalongkorn University
Chulalongkorn University
June 2011

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