Maternal Antiviral Treatment and Infants Immunoprophylaxis in the Prevention of Mother-to-child Transmission

Hepatitis B Clinical Trial

Official title:

Maternal Nucleos(t)Ide Analogue Use and Infants Immunoprophylaxis to Eliminate Hepatitis B Infection in the Real World Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977987
• Other study ID #: RWD-0
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2019
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effective control of nucleos(t)ide analogues for patients infected with hepatitis B has significantly curbed the horizontal transmission of hepatitis B. However, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis B worldwide with the transmission rate up to 80 to 90% among high HBV DNA level if untreated. Currently, the effective prevention of mother-to-child transmission is credited to the implement of HBV vaccination and hepatitis B virus immunoglobin. To leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. However, the clinical practice can be more complex. Therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis B infection in the real world setting.

Description:

From 2011 to 2017, the investigators consecutively enrolled the pregnant women with chronic hepatitis B infection who were less than 28 weeks pregnant and not treated with nucleos(t)ide analogues during pregnancy. The investigators recommended those pregnant women with HBV DNA > 2*10^6 IU/ml to receive nucleos(t)ide analogues from 28 weeks of pregnancy to delivery. Patients who agreed the antiviral treatment would assigned to the treatment group and those who declined it were assigned to the control group with high HBV DNA level. Meanwhile, those pregnant women with HBV DNA < 2*10^6 IU/ml was assigned as the control group with low HBV DNA level. All infants would be instructed to receive hepatitis B vaccine and hepatitis B virus immunoglobulin within 24 hours after birth, defined as the standard immunoprophylaxis strategy and encouraged to receive immunoprophylaxis within 2 hours after birth, defined as the aggressive immunoprophylaxis strategy. Umbilical cord blood were collected to determine the HBV serological markers and HBV DNA level. Children were followed every three to four years until December 2018.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy

Exclusion Criteria:

• women treated with antiviral drugs during pregnancy.

• drug hypersensitivity;

• abnormal renal laboratory results;

• coinfection with human immunodeficiency virus or other human hepatitis viruses.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Drug:
• nucleos(t)ide analogue
Pregnant women in this group agree to receive nucleos(t)ide analogue (tenofovir or telbivudine) daily from the 28 weeks of pregnancy to delivery.

Locations

Country	Name	City	State
China	The First People's Hospital of Taicang	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of children who developed chronic HBV infection between the treatment group and two control groups in the real-world setting.	We compare the proportion of children with chronic HBV born to mothers from three groups in the real life setting	December, 2018
Secondary	the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the standardized immunoprophylaxis strategy	We compare the proportion of children with chronic HBV born to mothers from three groups who followed the standardized immunoprophylaxis strategy	December, 2018
Secondary	the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the aggressive immunoprophylaxis strategy	We compare the proportion of children with chronic HBV born to mothers from three groups who followed the aggressive immunoprophylaxis strategy	December, 2018
Secondary	The proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood	We compare the proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood born to mothers from three groups	At delivery
Secondary	The HBV DNA level of mothers among three groups	We compare the HBV DNA level of mothers among three groups within one week before delivery.	Within one week before delivery.