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

• Conditions: Chronic Hepatitis B Infection; High Viral Load
• Interventions: Drug: TAF; Drug: TDF

• Registration Number: NCT04135235
• Lead Sponsor: Beijing Ditan Hospital

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.

Study Timeline

• Study Start: 2019-08-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-12
• Study First Submitted QC: 2019-10-19
• Last Update Submitted: 2019-10-19
• Study First Posted: 2019-10-22
• Last Update Posted: 2019-10-22
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 440

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAF group	TAF	take propofol fumarate for Maternal and child blockade treatment
TDF group	TDF	take difenofurate fumarate for Maternal and child blockade treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China