The COMBAT HBV Feasibility Trial

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

317

Participants

Timeline

Start Date

August 17, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Hepatitis BVertical Transmission of Infectious Disease
Interventions
DRUG

Tenofovir Disoproxil Fumarate 300 MG

Pregnant women in the experimental arm will receive TDF daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.

BIOLOGICAL

Hepatitis B monovalent vaccine

All infants born to women in the study will receive a birth-dose hepatitis B vaccine.

DRUG

Placebo

Pregnant women in the placebo arm will receive a placebo pill daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.

Trial Locations (1)

Unknown

Université Protestant au Congo, Kinshasa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Doris Duke Charitable Foundation

OTHER

collaborator

Université Protestant au Congo

UNKNOWN

collaborator

Abbott

INDUSTRY

collaborator

Albert Einstein College of Medicine

OTHER

lead

University of North Carolina, Chapel Hill

OTHER