Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission

PHASE4UnknownINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

June 10, 2018

Primary Completion Date

May 31, 2021

Study Completion Date

May 31, 2024

Conditions
Hepatitis B InfectionCongenital MalformationBirth DefectViremiaChronic Infection
Interventions
DRUG

Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.

All mothers will receive TDF therapy. However, group A will initiate TDF at the gestational week of 14-16, while group B will initiate TDF at the gestational week of 28. All infants will receive a series of three hepatitis B vaccines (at birth, age of weeks 4 and 24). In addition, the infants in the group B will receive HBIg injection at birth.

Trial Locations (7)

100069

RECRUITING

Beijing Youan Hospital, Capital Medical University, Beijing

400038

RECRUITING

Southwest Hospital, Chongqing

510623

RECRUITING

Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou

518112

RECRUITING

The Third People's Hospital of Shenzhen, Shenzhen

710061

RECRUITING

Department of Infectious Diseases, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

050021

RECRUITING

The Fifth Hospital of Shijiazhuang, Shijiazhuang

050051

RECRUITING

Shijiazhuang Maternal and Child Health Care Hospital, Shijiazhuang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

New Discovery LLC

INDUSTRY

NCT03476083 - Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission | Biotech Hunter | Biotech Hunter