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

Chronic Hepatitis B Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04135235
• Other study ID #: KY2019-08
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2019
• Source: Beijing Ditan Hospital
• Contact: Wei Yi, Doctor
• Phone: 13683687062
• Email: yiwei1215[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B Infection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• High Viral Load

Intervention

Drug:
• TAF
Propofol tenofovir fumarate
• TDF
Dipirofurate fumarate tenofovir

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of abnormal growth	The incidence of abnormal growth at birth	at birth, at the 7 months after birth
Secondary	The incidence of abnormal development	The incidence of abnormal development at birth	at birth, at the 7 months after birth