Status:
UNKNOWN
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
Lead Sponsor:
Chulalongkorn University
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
NA
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 impr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01243281
Start Date
March 1 2011
End Date
December 1 2013
Last Update
June 28 2011
Active Locations (1)
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1
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330