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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
Chronic hepatitis B (CHB) is prevalent in the world, with estimated chronic carriers of 350 millions worldwide. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir and peginterferon (52 weeks) | Experimental | Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52 |
|
| Peginterferon (96 weeks) | Experimental | Peginterferon alfa-2a 180 ug/week sc at week 1-96 |
|
| Peginterferon (48 weeks) | Active Comparator | Peginterferon alfa-2a 180 ug/week sc at week 1-48 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir and peginterferon (Pegasys) (52 weeks) | Drug | Entecavir 0.5 mg/day po at week 1-4 Peginterferon alfa-2a 180 ug/week sc at week 5-52 |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBV virologic response (HBV DNA < 2,000 IU/mL) 6 months after the cessation of treatment | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| ALT normalization rate (ALT < 40 IU/L) 6 months after the cessation of treatment | 2.5 years |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen-Hua Liu, MD | Contact | 886-2-23123456 | 63572 | jacque_liu@mail2000.com.tw |
| Jia-Horng Kao, MD, PhD | Contact | 886-2-23123456 | 67307 | kaojh@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chen-Hua Liu, MD | National Taiwan University Hospital | Study Chair |
| Jia-Horng Kao, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hosptial, Yun-Lin Branch | Recruiting | Douliu | Taiwan |
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|
| Peginterferon (Pegasys) (96 weeks) | Drug | Peginterferon alfa-2a 180 ug/week sc at week 1-96 |
|
|
| Peginterferon (Pegasys) (48 weeks) | Drug | Peginterferon alfa-2a 180 ug/week sc at week 1-48 |
|
|
| Shih-Jer Hsu, MD |
| National Taiwan University Hosptial, Yun-Lin Branch |
| Principal Investigator |
| Chih-Lin Lin, MD | Ren-Ai Branch, Taipei City Hospital | Principal Investigator |
| Cheng-Chao Liang, MD | Far Eastern Memorial Hospital | Principal Investigator |
| Ching-Sheng Hsu, MD | Buddhist Tzu Chi General Hospital | Principal Investigator |
| Sheng-Shun Yang, MD, PhD | Taichung Veterans General Hospital | Principal Investigator |
| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Buddhist Tzu Chi General Hospital | Recruiting | Taipei | Taiwan |
|
| Far Eastern Memorial Hospital | Recruiting | Taipei | Taiwan |
|
| Ren-Ai Branch, Taipei Municipal Hospital | Recruiting | Taipei | Taiwan |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| C100416 | peginterferon alfa-2a |
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