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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

Purpose

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	Intervention
Chronic Hepatitis B	Drug: PEG-IFN and entecavir


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Interferon Interferon Alfa-2b Entecavir Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

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:

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 ]


Estimated Enrollment:	126
Study Start Date:	March 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	November 17, 2010
Last Updated:	June 26, 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 Entecavir Interferon-alpha Peginterferon alfa-2b Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017

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