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To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.
Tenofovir Disoproxil Fumarate is a American Food and Drug Administration (FDA) pregnancy class B drug. To determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic HBV infection and high HBV DNA load. Pregnant women with high HBV DNA load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. The blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the HBV DNA load and liver functions will be tested. The status of HBV infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants and safety outcomes will be compared across the three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir 24 week | Experimental | Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum |
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| Tenofovir 28 week | Experimental | Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum |
|
| Tenofovir 32 week | Active Comparator | Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Drug | Use Tenofovir at 24week of gestation |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA load in serum | the difference in the percentage of mothers whose HBV DNA load in serum are less than 10*2 IU/ml at delivery among the groups | 40 weeks, from randomization to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Intrauterine HBV infection rate of infants | Intrauterine HBV infection rate of infants at the 12th months after delivery | 12 months, from delivery to one-year birth date |
| Change in HBV DNA load |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinfeng Liu, MB | Contact | +86-13259927840 | prettycaofurong@163.com | |
| Jing Wang, MD,PHD | Contact | +86-18092691661 | kidip@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tianyan Chen, MD,PHD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | 710061 | China |
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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 |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Tenofovir Disoproxil Fumarate | Drug | Use Tenofovir at 28week of gestation |
|
|
| Tenofovir Disoproxil Fumarate | Drug | Use Tenofovir at 32week of gestation |
|
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Total change in HBV DNA load from the start of treatment to the delivery was compared across the three groups
| 40 weeks, from randomization to delivery |
| Change in hepatitis B e antigen (HBeAg) titer | Total change in HBeAg titer from the start of treatment to the delivery was compared across the three groups | 40 weeks, from randomization to delivery |
| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |