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Entecavir and Peginterferon Alfa-2a Sequential Therapy Versus Peginterferon Alfa-2a Monotherapy for HBeAg Negative Chronic Hepatitis B
Sponsor study identifier
interventional
300
1 country
6
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg negative CHB, with the overall ALT normalization and HBV viral suppression far from satisfactory. Therefore, efforts on the various combinations with the currently available drugs are needed to improve the overall response rates. The simultaneous combination therapy with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that early viral suppression by lamivudine can restore the immune function to facilitate the later immunomodulatory response by peginterferon alfa-2a. Furthermore, prior studies using 24 months of standard interferon alfa showed better ALT normalization and HBV suppression rates to 12 months of therapy. With the recent introduction of entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of peginterferon alfa-2a to achieve HBV viral suppression. Therefore, we aimed to conduct a placebo controlled randomized control trial to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 8, 2009
Actual (reported)June 10, 2009
Actual (reported)December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
HBV virologic response (HBV DNA < 2,000 IU/mL) 6 months after the cessation of treatment
2.5 years
ALT normalization rate (ALT < 40 IU/L) 6 months after the cessation of treatment
2.5 years
Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52
Peginterferon alfa-2a 180 ug/week sc at week 1-96
Peginterferon alfa-2a 180 ug/week sc at week 1-48
Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52
Peginterferon alfa-2a 180 ug/week sc at week 1-96
National Taiwan University Hosptial, Yun-Lin Branch
Douliu, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chen-Hua Liu, MD
National Taiwan University Hospital
Jia-Horng Kao, MD, PhD
National Taiwan University Hospital
Shih-Jer Hsu, MD
National Taiwan University Hosptial, Yun-Lin Branch
Chih-Lin Lin, MD
Ren-Ai Branch, Taipei City Hospital
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
February 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)Peginterferon alfa-2a 180 ug/week sc at week 1-48
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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National Taiwan University Hospital
Taipei, 10002, Taiwan
Buddhist Tzu Chi General Hospital
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
Ren-Ai Branch, Taipei Municipal Hospital
Taipei, Taiwan
Cheng-Chao Liang, MD
Far Eastern Memorial Hospital
Ching-Sheng Hsu, MD
Buddhist Tzu Chi General Hospital
Sheng-Shun Yang, MD, PhD
Taichung Veterans General Hospital
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 20, 2012
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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