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| Name | Class |
|---|---|
| Major Science and Technology Special Project of China Eleventh Five-year | OTHER |
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir | Drug | Adefovir 10 mg po once daily for 36 weeks |
| |
| peginterferon alfa-2a [PEGASYS] |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) | Weeks 72, 96, 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml | Weeks 24, 48, 72, 96, 120 | |
| Safety: Adverse Events | From baseline to Week 120 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100011 | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27238752 | Derived | Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26. |
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| Drug |
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks |
|
| peginterferon alfa-2a [PEGASYS] | Drug | Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks |
|
| peginterferon alfa-2a [PEGASYS] | Drug | Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks |
|
| Beijing |
| 100034 |
| China |
| Beijing | 100044 | China |
| Beijing | 100050 | China |
| Changchun | 130021 | China |
| Guangzhou | 510515 | China |
| Shanghai | 200025 | China |
| Shanghai | 200040 | China |
| Shanghai | 200433 | China |
| Wuhan | 430030 | China |
| Xi'an | 710038 | China |
| 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 |
|---|---|
| C053001 | adefovir |
| C100416 | peginterferon alfa-2a |
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