Clinical trial NCT04135235: Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
Official title: The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B Infection
High Viral Load
Keywords: Chronic Hepatitis B
Pregnant woman
High viral load
Tenofovir fumarate
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High HBV viral load (HBV DNA ≥ 106 IU / mL) pregnant women with chronic HBV infection. All pregnant women with chronic HBV infection were in compliance with the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the blocking successful rate of HBV mother-to-child transmission
timeFrame: 7 months after birth
Secondary outcomes:
measure: The incidence of abnormal growth
timeFrame: at birth, at the 7 months after birth
measure: The incidence of abnormal development
timeFrame: at birth, at the 7 months after birth
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Wei Yi, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References: