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

Chulalongkorn University

Status

Unknown

Conditions

Chronic Hepatitis B

Treatments

Drug: PEG-IFN and entecavir

Study type

Interventional

Funder types

Other

Identifiers

NCT01243281

Biochem2010/01

Details and patient eligibility

About

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

Enrollment

126 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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