Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
Primary Purpose
Chronic Hepatitis B, Mother-to-child Block, Antiviral Treatment
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Tenofovir Alafenamide 25 MG
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Hepatitis B
Eligibility Criteria
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.
Sites / Locations
- LinChaoshuangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pregnant women with CHB
women with CHB
Arm Description
Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected.
Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.
Outcomes
Primary Outcome Measures
Liver indicators of intrapartum
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04507607
First Posted
July 18, 2020
Last Updated
December 21, 2020
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT04507607
Brief Title
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
Official Title
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
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 to enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Mother-to-child Block, Antiviral Treatment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women with CHB
Arm Type
Experimental
Arm Description
Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected.
Arm Title
women with CHB
Arm Type
Active Comparator
Arm Description
Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide 25 MG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Liver indicators of intrapartum
Description
The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.
Time Frame
intrapartum
Title
Liver indicators of postpartum
Description
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.
Time Frame
12 months postpartum
Secondary Outcome Measure Information:
Title
Liver indicators of pregnancy
Description
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.
Time Frame
24 weeks gestation until delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
LinChaoshuang
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LiXin Xiao
Phone
18613016355
Email
amia1995@163.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection
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