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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment
Chronic Hepatitis B Drug: PEG-IFN and entecavir

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: drug combination 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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243281


Contacts
Contact: Pisit Tangkijvanich, M.D. +662-256-4482 pisittkvn@yahoo.com

Locations
Thailand
Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Pisit Tangkijvanich, M.D.    +662-256-4482    pisittkvn@yahoo.com   
Principal Investigator: Pisit Tangkijvanich, M.D.         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Pisit Tangkijvanich, M.D. Chulalongkorn University
More Information

Responsible Party: Dr. Pisit Tangkijvanich, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01243281     History of Changes
Other Study ID Numbers: Biochem2010/01
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by Chulalongkorn University:
hepatitis B
HBeAg
pegylated interferon
entecavir

Additional relevant MeSH terms:
Hepatitis
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
Interferons
Interferon-alpha
Entecavir
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs