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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 HBsAg positive patients in prevention of HBV vertical transmission. Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery.
Single group patients were enrolled to receive emtricitabine till 24 weeks after delivery, which include HBeAg positive patients. Patients and their newborns were followed till 48 weeks after delivery to evaluate the efficacy of prevention of vertical transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese naive pregnant HBsAg positive patients | Experimental | single group patients were enrolled to receive emtricitabine(200mg one time per day) till 24 weeks after dilivery,patients and followed up for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine | Drug | emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg positive rate in newborns | HBsAg positive rate in newborns | week48 after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| birth defect in newborns | birth defect in newborns | 0 weeks, week24 and week48 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 |
| 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 |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| week 24 after delivery |
| HBV DNA decrease level | HBV DNA decrease compared with baseline(log10 copies/ml) | week 24 after delivery |
| biochemical response | ALT normalization | week 24 after delivery |
| HBeAg loss | HBeAg loss in HBeAg positive patients | week 24 after delivery |
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24 after delivery |
| HBV genetic resistance to emtricitabine | HBV genetic resistance to emtricitabine | week 24 after delivery |
| adverse event | type and rate of adverse events;type and rate of severe adverse event | week 24 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. |
| 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 |