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

Not Applicable

• Conditions: Chronic Hepatitis B
• Interventions: Drug: PEG-IFN and entecavir

• Registration Number: NCT01243281
• Lead Sponsor: Chulalongkorn University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Study Start: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-26
• Last Update Posted: 2011-06-28
• Primary Completion: 2013-05
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug combination	PEG-IFN and entecavir	-

Primary Outcome Measures

Name	Time	Method
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	24 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment	24 weeks post treatment

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand