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The COMBAT HBV Feasibility Trial

NCT05705427 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2026-02-19

No results posted yet for this study

Summary

This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC). HBV-infected pregnant women will be randomized to either receive tenofovir or placebo beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Women will be followed every 4-6 weeks throughout the prenatal and postpartum period to evaluate for side effects related to the medication. Infants will receive a birth-dose of HBV vaccine, ideally within 24 hours. Participants will be followed longitudinally through 6 months' postpartum.

Conditions

  • Hepatitis B
  • Vertical 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.

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Université Protestant au Congo

    collaborator UNKNOWN

  • Abbott

    collaborator INDUSTRY

  • Albert Einstein College of Medicine

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Peyton Thompson, MD, MSCR · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2025-11-25
Completion
2025-11-25
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705427 on ClinicalTrials.gov