Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Tenofovir Disoproxil Fumarate
* Drug: Tenofovir Disoproxil Fumarate
* Drug: Tenofovir Disoproxil Fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 20 and 40 years old Have had HBsAg positive in serum greater than 6 months HBV DNA load>10**6 IU/ml Gestation week<24 weeks Normal liver function Able to comprehend and willing to sign the informed consent form Exclusion Criteria: Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV) Got antiviral treatments before 24 weeks of Gestation Got immunosuppressor treatment and/or steroids Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B Got serious obstetric complications Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination Biological father of infant had HBV infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir 24 week<br>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 | Drug: Tenofovir Disoproxil Fumarate<br>* Use Tenofovir at 24week of gestation<br>* Other names: Tenofovir;|
| Experimental: Tenofovir 28 week<br>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 | Drug: Tenofovir Disoproxil Fumarate<br>* Use Tenofovir at 28week of gestation<br>* Other names: Tenofovir;|
| Active Comparator: Tenofovir 32 week<br>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 | Drug: Tenofovir Disoproxil Fumarate<br>* Use Tenofovir at 32week of gestation<br>* Other names: Tenofovir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertical infection transmission, Tenofovir