Chronic Hepatitis B Infection, High Viral Load
Conditions
Keywords
Chronic Hepatitis B, Pregnant woman, High viral load, Tenofovir fumarate
Brief summary
This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.
Detailed description
This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment.
Interventions
DRUGTAF
Propofol tenofovir fumarate
DRUGTDF
Dipirofurate fumarate tenofovir
Sponsors
Beijing Ditan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* No nucleoside analog antiviral drugs have been used in the past. * HBsAg and HBeAg double positive, HBV DNA\>106 IU/mL. * Fully inform the risk to voluntarily join the study and sign the informed consent form.
Exclusion criteria
* Combine other viral infections: such as HCV, HIV, CMV, etc.; * amniocentesis during pregnancy; * Liver cirrhosis and liver cancer; * Other autoimmune diseases and liver diseases; * fetal ultrasound screening in early and middle pregnancy found deformity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the blocking successful rate of HBV mother-to-child transmission | 7 months after birth | HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of abnormal growth | at birth, at the 7 months after birth | The incidence of abnormal growth at birth |
| The incidence of abnormal development | at birth, at the 7 months after birth | The incidence of abnormal development at birth |
Countries
China
Contacts
Primary ContactWei Yi, Doctor
Backup ContactYao Xie, Doctor
Outcome results
None listed