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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) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.
Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese naive pregnant chronice hepatitis B | Experimental | Chinese naive pregnant chronice hepatitis B were enrolled to take emtricitabine (200 mg one time per day) till 48 weeks after delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine | Drug | emtricitabine were given to each patients at baseline till 48 weeks after delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| virological response rate | HBV DNA < 500 copies/ml | week 48 after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 copies/ml） | week 24 and 48 after delivery |
| virological response 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 |
|---|---|---|---|
| 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 |
| 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 after delivery |
| biochemical response | ALT normalization | week 24 and 48 after delivery |
| HBeAg loss | HBeAg loss in HBeAg positive group | week 24 and 48 after delivery |
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24 and 48 after delivery |
| HBeAg reversion | HBeAg positive in Baseline HBeAg negativie group patients | week 24 and 48 after delivery |
| HBsAg loss | HBsAg loss | week 24 and 48 after delivery |
| HBsAg seroconversion | HBsAg loss and anti-HBs positive | week 24 and 48 after delivery |
| HBV genetic resistance to emtricitabine | HBV genetic resistance to emtricitabine | week 24 and 48 after delivery |
| adverse event | type and rate of adverse events;type and rate of severe adverse event; | week 24 and 48 after delivery |
| birth defect in newborns | birth defect in newborns | 0 weeks, week24 and week48 after delivery |
| HBsAg positive rate in newborns | HBsAg positive rate in newborns | 0 weeks, week24 and week48 after delivery |
| 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. |
| 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 |