Hepatitis B, Chronic
Conditions
Keywords
Vertical infection transmission, Tenofovir
Brief summary
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
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.
Interventions
DRUGTenofovir Disoproxil Fumarate
Use Tenofovir at 24week of gestation
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA load in serum | 40 weeks, from randomization to delivery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrauterine HBV infection rate of infants | 12 months, from delivery to one-year birth date | Intrauterine HBV infection rate of infants at the 12th months after delivery |
| Change in HBV DNA load | 40 weeks, from randomization to delivery | Total change in HBV DNA load from the start of treatment to the delivery was compared across the three groups |
| Change in hepatitis B e antigen (HBeAg) titer | 40 weeks, from randomization to delivery | Total change in HBeAg titer from the start of treatment to the delivery was compared across the three groups |
Countries
China
Contacts
Primary ContactJinfeng Liu, MB
Backup ContactJing Wang, MD,PHD
Outcome results
None listed