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| Name | Class |
|---|---|
| Beijing Ditan Hospital | OTHER |
| Hebei Medical University Pharmaceutical Factory | INDUSTRY |
| National Health and Family Planning Commission, P.R.China | OTHER_GOV |
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This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBeAg positive CHB group | Experimental | 1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined |
|
| HBeAg negativie CHB group | Experimental | 1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine | Drug | emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| virological response rate | HBV DNA < 500 copies/ml | week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 copies/ml） | week24, 48, 72 and 96 |
| HBV DNA negativity rate | HBV DNA < 500 copies/ml |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Cheng, M.D. | Contact | +86 10 84322116 | jun.cheng.ditan@gmail.com | |
| Song Yang, M.D. | Contact | +86 15011210692 | sduyangsong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Cheng, M.D. | Asian Pacific Alliance of Liver Diseases, Beijing | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16401810 | Background | Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49. | |
| 12019083 |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| week 24, 48 and 72 |
| biochemical response | ALT normalization | week 24,48,72 and 96 |
| HBeAg loss | HBeAg loss in HBeAg positive group | week 24,48,72 and 96 |
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24,48,72 and 96 |
| HBeAg reversion | HBeAg positive in Baseline HBeAg negativie group patients | week 24,48,72 and 96 |
| HBsAg loss | HBsAg loss in both group | week 24,48,72 and 96 |
| HBsAg seroconversion | HBsAg loss and anti-HBs positive | week 24,48,72 and 96 |
| adverse event | type and rate of adverse events;type and rate of severe adverse event; | week 24,48,72 and 96 |
| HBV genetic resistance to emtricitabine and adefovir | HBV genetic resistance to emtricitabine and adefovir | week 24,48,72 and 96 |
| Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002. |
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |