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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Hepatitis B Infection High Viral Load

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAF group

take propofol fumarate for Maternal and child blockade treatment

TAF

Intervention Type DRUG

Propofol tenofovir fumarate

TDF group

take difenofurate fumarate for Maternal and child blockade treatment

TDF

Intervention Type DRUG

Dipirofurate fumarate tenofovir

Interventions

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TAF

Propofol tenofovir fumarate

Intervention Type DRUG

TDF

Dipirofurate fumarate tenofovir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No