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The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adefovir Dipivoxil | Experimental | ADV 10mg tablets once daily |
|
| Adefovir Dipivoxil matched placebo | Placebo Comparator | Adefovir Dipivoxil matched placebo one tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAAA | Drug | Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with ALT normalisation | Week 52, 104, 156, 208, 260 | |
| log10 reduction in serum HBV DNA | Week 52, 104, 156, 208, 260 | |
| The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guangzhou | Guangdong | 510515 | China | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2017 | |
| Unrelease | Yes | |
| Release | Dec 8, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2017 | Yes | |||
| Dec 8, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| AAPA | Drug | Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks) |
|
| PAAA | Drug | Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks) |
|
| Week 52, 104, 156, 208, 260 |
| The proportion of subjects with HBeAg loss | Week 52, 104, 156, 208, 260 |
| The proportion of subjects with HBeAg seroconversion | Week 52, 104, 156, 208, 260 |
| The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance | Week 52, 104, 156, 208, 260 |
| The proportion of subjects with HBV DNA undetectable (<300 copies/mL) | Week 52, 104, 156, 208, 260 |
| Guangzhou |
| Guangdong |
| 510630 |
| China |
| GSK Investigational Site | Changchun | Jilin | 130021 | China |
| GSK Investigational Site | Jinan | Shandong | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| GSK Investigational Site | Beijing | 100011 | China |
| GSK Investigational Site | Beijing | 100044 | China |
| GSK Investigational Site | Chongqing | 400038 | China |
| GSK Investigational Site | Chongquin | 400038 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| 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 |