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Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention |
| |
| telbivudine | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telbivudine treatment | Drug | Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety | From late pregnancy to 28 weeks of postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg | From late pregnancy to 28 weeks of postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University | Nanjing | Jiangsu | 210003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22343511 | Derived | Pan CQ, Han GR, Jiang HX, Zhao W, Cao MK, Wang CM, Yue X, Wang GJ. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol. 2012 May;10(5):520-6. doi: 10.1016/j.cgh.2012.01.019. Epub 2012 Feb 14. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D011248 | Pregnancy Complications |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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