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The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.
180 eligible subjects will be included.According to the set grouping method of dose escalation.Subjects will be randomized in a 1:1:1:1 proportion of Metacavir Enteric-coated Capsules(80mg/160mg/320mg) group,positive control group or placebo control group.Each group has 36 subjects.
1.Subjects will use the study medication(2 hours before or after meal,once a day) from Visit 3 to Visit 5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metacavir Enteric-coated Capsule 80mg | Experimental |
|
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| Metacavir Enteric-coated Capsules 160mg | Active Comparator |
|
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| Metacavir Enteric-coated Capsules 320mg | Placebo Comparator |
|
|
| Adefovir Dipivoxil Capsule | Active Comparator |
|
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metacavir Enteric-coated Capsules 80mg | Drug | Metacavir Enteric-coated Capsules 80mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment. | The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.(Unit:log10) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-chronic hepatitis B |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maorong Wang | Contact | 025-80864021 |
| Name | Affiliation | Role |
|---|---|---|
| Maorong Wang | 81 Military Hospital of China | Principal Investigator |
| Yonggang Li | Beijing 302 Hospital | Principal Investigator |
| Yongfeng Yang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 81 Military Hospital of China | Recruiting | Nanjing | Jiangsu | China |
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| Placebo Comparator |
|
|
| Metacavir Enteric-coated Capsules 160mg | Drug | Metacavir Enteric-coated Capsules 160mg |
|
| Metacavir Enteric-coated Capsules 320mg | Drug | Metacavir Enteric-coated Capsules 320mg |
|
| Metacavir Enteric-coated Capsules Placebo 240mg | Drug | Metacavir Enteric-coated Capsules Placebo 240mg |
|
| Metacavir Enteric-coated Capsules Placebo 160mg | Drug | Metacavir Enteric-coated Capsules Placebo 160mg |
|
| Metacavir Enteric-coated Capsules Placebo 320mg | Drug | Metacavir Enteric-coated Capsules Placebo 320mg |
|
| Adefovir Dipivoxil Capsule10mg | Drug | Adefovir Dipivoxil Capsule10mg |
|
| Adefovir Dipivoxil Capsule Placebo 10mg | Drug | Adefovir Dipivoxil Capsule Placebo 10mg |
|
| 12 weeks |
| Incidence of Adverse Events(AEs) | 48 weeks |
| The Second Hospital of Nanjing Medical University |
| Principal Investigator |
| Yanlin Yu | Wannan Medical College Yijishan Hospital | Principal Investigator |
| Jun Li | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| 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 |
|---|---|
| C106812 | adefovir dipivoxil |
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