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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) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| compensated HBV related cirrhosis patients | Experimental | Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks |
|
| decompensated HBV related cirrhosis patients | Experimental | Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine plus adefovir dipivoxil | Drug | emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| virological response rate | HBV DNA < 500 copies/ml | week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA negativity rate | HBV DNA < 500 copies/ml | week 24, 48 and 72 |
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 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 |
|---|---|---|---|
| 12019083 | Background | 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. | |
| 16401810 |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D005355 | Fibrosis |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| C106812 | adefovir dipivoxil |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| week24, 48, 72 and 96 |
| 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 |
| HBV genetic resistance to emtricitabine and adefovir | HBV genetic resistance to emtricitabine and adefovir | 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 |
| incidence of HCC | incidence of HCC in both groups | week 24,48,72 and 96 |
| change of MELD score and Child-Pugh score | change of MELD score and Child-Pugh score in both groups | week 24,48,72 and 96 |
| 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. |
| 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 |