Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
1 other identifier
observational
440
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 12, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedOctober 22, 2019
October 1, 2019
2 years
October 12, 2019
October 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the blocking successful rate of HBV mother-to-child transmission
HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth)
7 months after birth
Secondary Outcomes (2)
The incidence of abnormal growth
at birth, at the 7 months after birth
The incidence of abnormal development
at birth, at the 7 months after birth
Study Arms (2)
TAF group
take propofol fumarate for Maternal and child blockade treatment
TDF group
take difenofurate fumarate for Maternal and child blockade treatment
Interventions
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Yi, Doctor
Beijing Ditan Hospital
- PRINCIPAL INVESTIGATOR
Yao Xie, Doctor
Beijing Ditan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of Obstetrics and Gynecology
Study Record Dates
First Submitted
October 12, 2019
First Posted
October 22, 2019
Study Start
August 1, 2019
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
October 22, 2019
Record last verified: 2019-10