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Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

NCT ID: NCT03695029

Last Updated: 2020-11-27

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-29

Study Completion Date

2021-12-31

Brief Summary

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To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

Detailed Description

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This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Conditions

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Hepatitis B Virus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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treatment group

Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

Group Type EXPERIMENTAL

Tenofovir Alafenamide

Intervention Type DRUG

Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

control group

control group receive no drug, only follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tenofovir Alafenamide

Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged 20-45 years in 28 to 32 weeks of pregnancy
* Positive HBsAg and HBeAg
* Serum viral load above 6 log10 IU/mL

Exclusion Criteria

* Major systemic disease of the mother or fetus
* Positive anti-HIV or anti-HCV
* Under treatment of antiviral therapy
* Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
* Pregnant woman whose amniocentesis reveals any genetic abnormality
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mei-Hwei Chang

Role: CONTACT

Phone: +886-2-23123456

Email: [email protected]

Facility Contacts

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Ivy Chiou

Role: primary

References

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Chen HL, Lee CN, Chang CH, Lai MW, Tsai MC, Mu SC, Liu CJ, Shih JC, Wen WH, Hu RT, Huang CP, Hu KC, Chen CP, Lee CL, Chien RN, Chang KC, Hsu HY, Lee CC, Ni YH, Chang MH. Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes. Liver Int. 2024 Jun;44(6):1422-1434. doi: 10.1111/liv.15873. Epub 2024 Mar 8.

Reference Type DERIVED
PMID: 38456620 (View on PubMed)

Other Identifiers

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201010078M

Identifier Type: -

Identifier Source: org_study_id