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ACTIVE NOT RECRUITING
NCT03343431
PHASE3

Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection

Sponsor: Institut de Recherche pour le Developpement

View on ClinicalTrials.gov

Summary

Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.

Official title: A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

504

Start Date

2018-08-02

Completion Date

2025-06-30

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

DRUG

Anti-HBV antiviral prophylaxis

Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum

Locations (20)

Champasak Hospital

Champasak, Laos

Luang Prabang Provincial Hospital

Luang Prabang, Laos

Sayaboury Hospital

Sainyabuli, Laos

Savannakhet Provincial hospital

Savannakhet, Laos

103 Hospital

Vientiane, Laos

Mahosot Hospital

Vientiane, Laos

Mother and Newborn Hospital

Vientiane, Laos

Setthathirath Hospital

Vientiane, Laos

Chiang Kham Hospital

Chiang Kham, Changwat Phayao, Thailand

Nopparat Rajathanee Hospital

Bangkok, Thailand

Prapokklao Hospital

Chanthaburi, Thailand

Health Promotion Center Region 1

Chiang Mai, Thailand

Nakornping Hospital

Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand

Chonburi Hospital

Chon Buri, Thailand

Banglamung Hospital

Chon Buri, Thailand

Lampang Hospital

Lampang, Thailand

Lamphun Hospital

Lamphun, Thailand

Samutprakarn Hospital

Mueang Samut Prakan, Thailand

Samutsakhon Hospital

Samut Sakhon, Thailand