Clinical trial NCT01243281: Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: hepatitis B
HBeAg
pegylated interferon
entecavir
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 24 weeks post treatment
Secondary outcomes:
measure: To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment
timeFrame: 24 weeks post treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Pisit Tangkijvanich, M.D.
role: PRINCIPAL_INVESTIGATOR
References: