Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B

Capital Medical University

Status: Unknown

Conditions: Chronic Hepatitis B Infection; High Viral Load

Treatments: Drug: TAF; Drug: TDF

Study type: Observational

Funder types: Other

Identifiers

NCT04135235

KY2019-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

440 participants in 2 patient groups

TAF group

Description:

take propofol fumarate for Maternal and child blockade treatment

Treatment:

Drug: TAF

TDF group

Description:

take difenofurate fumarate for Maternal and child blockade treatment

Treatment:

Drug: TDF