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

Sponsor

Beijing Ditan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04135235

Collaborator

(none)

440

Enrollment

Location

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B Infection High Viral Load	Drug: TAF Drug: TDF

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

The effectiveness and safety of the treatment.

Study Design

Study Type:

Observational

Anticipated Enrollment :

440 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
TAF group take propofol fumarate for Maternal and child blockade treatment	Drug: TAF Propofol tenofovir fumarate
TDF group take difenofurate fumarate for Maternal and child blockade treatment	Drug: TDF Dipirofurate fumarate tenofovir

Arm

Intervention/Treatment

TAF group

take propofol fumarate for Maternal and child blockade treatment

Drug: TAF

Propofol tenofovir fumarate

TDF group

take difenofurate fumarate for Maternal and child blockade treatment

Drug: TDF

Dipirofurate fumarate tenofovir

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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.