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

NCT ID: NCT04507607

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis B Mother-to-child Block Antiviral Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pregnant women with CHB

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.

Group Type EXPERIMENTAL

Tenofovir Alafenamide 25 MG

Intervention Type DRUG

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.

women with CHB

Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.

Group Type ACTIVE_COMPARATOR

Tenofovir Alafenamide 25 MG

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Chaoshuang Lin

Professor Lin

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LinChaoshuang

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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LiXin Xiao

Role: primary

Other Identifiers

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0237801

Identifier Type: -

Identifier Source: org_study_id