Status:
UNKNOWN
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Chronic Hepatitis B
Mother-to-child Block
Eligibility:
FEMALE
18-60 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04507607
Start Date
August 1 2020
End Date
June 30 2021
Last Update
December 22 2020
Active Locations (1)
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1
LinChaoshuang
Guangzhou, China