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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Chulalongkorn University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01243281
First received: November 17, 2010
Last updated: June 26, 2011
Last verified: June 2011

November 17, 2010
June 26, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01243281 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
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
Both
18 Years to 65 Years
No
Contact: Pisit Tangkijvanich, M.D. +662-256-4482 pisittkvn@yahoo.com
Thailand
 
NCT01243281
Biochem2010/01
Yes
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