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This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAF antiviral therapy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Alafenamide Fumarate tablets | Drug | Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| MTCT rates in the TAF treated mothers | detectable levels of HBV DNA or HBsAg in the peripheral serum samples of infants at age 28 weeks | 28 weeks post-partum |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women in the Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) whose HBsAg and HBeAg are positive are enrolled in the study. TAF is used as antiviral therapy during 24-28 week of gestation.The safety and efficacy of TAF are evaluated.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guorong Han | Contact | 13851623507 | hgr518@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) | Recruiting | Nanjing | Jiangsu | 210003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36253882 | Derived | Han G, Zhou G, Sun T, Luo X, Xu J, Chen C, Xu W, Jiang S, Wang C. Tenofovir alafenamide in blocking mother-to-child transmission of hepatitis B virus: a multi-center, prospective study. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10551-10558. doi: 10.1080/14767058.2022.2134771. Epub 2022 Oct 17. |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |