Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
NCT ID: NCT01243281
Last Updated: 2011-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
126 participants
INTERVENTIONAL
2011-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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drug combination
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Faculty of Medicine, Chulalongkorn University
Principal Investigators
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Pisit Tangkijvanich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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Faculty of Medicine, Chulalongkorn University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Biochem2010/01
Identifier Type: -
Identifier Source: org_study_id
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