Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
Study NCT ID:
NCT04135235
Status:
UNKNOWN
Last Update Posted:
2019-10-22
First Post:
2019-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
Sponsor:
Beijing Ditan Hospital
Organization:
Study Overview
Official Title:
The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: