Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

PHASE3CompletedINTERVENTIONAL
Enrollment

654

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

October 31, 2018

Conditions
Hepatitis B Chronic InfectionPregnancy
Interventions
DRUG

tenofovir disoproxil fumarate

administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum

DRUG

placebo

administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum

Trial Locations (17)

10220

Bhumibol Adulyadej Hospital, Bangkok

10230

Nopparat Rajathanee Hospital, Bangkok

10280

Samutprakarn Hospital, Mueang Samut Prakan

20000

Chonburi Regional Hospital, Chon Buri

20150

Banglamung Hospital, Bang Lamung

22000

Prapokklao Hospital, Chanthaburi

30000

Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima

40000

Khon Kaen Hospital, Khon Kaen

50100

Health Promotion Center Region 10, Chiang Mai

50180

Nakornping Hospital, Chiang Mai

51000

Lamphun Hospital, Lamphun

52000

Lampang Hospital, Lampang

56000

Phayao Provincial Hospital, Phayao

56110

Chiang Kham Hospital, Chiang Kham

57000

Chiangrai Prachanukroh Hospital, Chiang Rai

57110

Mae Chan Hospital, Mae Chan

74000

Samutsakhon Hospital, Samut Sakhon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Centers for Disease Control and Prevention

FED

collaborator

Gilead Sciences

INDUSTRY

lead

Institut de Recherche pour le Developpement

OTHER_GOV

NCT01745822 - Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand | Biotech Hunter | Biotech Hunter