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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B Infection; High Viral Load
• Intervention / Treatment: Drug: TAF; Drug: TDF

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 Type: Observational
• Enrollment (Anticipated): 440

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Recruiting
      • Beijing Ditan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAF group; take propofol fumarate for Maternal and child blockade treatment	Drug: TAF; Propofol tenofovir fumarate
TDF group; take difenofurate fumarate for Maternal and child blockade treatment	Drug: TDF; Dipirofurate fumarate tenofovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of abnormal growth	The incidence of abnormal growth at birth	at birth, at the 7 months after birth
The incidence of abnormal development	The incidence of abnormal development at birth	at birth, at the 7 months after birth

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital
• Investigators: Principal Investigator: Wei Yi, Doctor, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 19, 2019
• First Posted (ACTUAL): October 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pregnant woman; Chronic Hepatitis B; High viral load; Tenofovir fumarate
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: KY2019-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No