Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

Chronic Hepatitis B Clinical Trial

Official title:

Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04507607
• Other study ID #: 0237801
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2020
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.

Description:

After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 25 pregnant women with HBeAg (+), HBV DNA = 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.

• 25 non-pregnant women with HBeAg (+), HBV DNA = 2*10^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.

• The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.

Exclusion Criteria:

• Coinfection with HAV, HCV, HDV, HEV or HIV;

• A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;

• Three-dimensional ultrasonography showed fetal malformation;

• The spouse is infected with HBV;

• History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;

• History of immune diseases;

• A history of serious cardiovascular disease;

• Other reasons the researchers considered it inappropriate to participate in the trial.

Related Conditions & MeSH terms

• Antiviral Treatment
• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Mother-to-child Block

Intervention

Drug:
• Tenofovir Alafenamide 25 MG
TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.

Locations

Country	Name	City	State
China	LinChaoshuang	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver indicators of intrapartum	The level of liver function (ALT?AST)?HBV DNA?HBV Serological markers (HBsAg?HBeAg?HBeAb) in pregnant women at birth.	intrapartum
Primary	Liver indicators of postpartum	The level of liver function (ALT?AST)?HBV DNA?HBV Serological markers (HBsAg?HBeAg?HBeAb) in pregnant women 1 month?3 month?7 month?9 month?12 month after delivery.	12 months postpartum
Secondary	Liver indicators of pregnancy	The level of liver function (ALT?AST)?HBV DNA?HBV Serological markers (HBsAg?HBeAg?HBeAb) in pregnant women taking TAF 0?4?8?12 weeks.	24 weeks gestation until delivery