Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
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
1 other identifier
interventional
126
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 18, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJune 28, 2011
June 1, 2011
2.2 years
November 17, 2010
June 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment
24 weeks post treatment
Study Arms (1)
drug combination
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pisit Tangkijvanich, M.D.
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 18, 2010
Study Start
March 1, 2011
Primary Completion
May 1, 2013
Study Completion
December 1, 2013
Last Updated
June 28, 2011
Record last verified: 2011-06