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Arresting Vertical Transmission of Hepatitis B Virus

NCT03567382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2021-02-24

Study results available
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Summary

The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.

Conditions

  • Hepatitis B
  • Vertical Transmission of Infectious Disease

Interventions

DRUG

Tenofovir Disoproxil Fumarate

300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.

BIOLOGICAL

Monovalent HBV vaccine

Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Sponsors & Collaborators

  • Kinshasa School of Public Health

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Steven Meshnick, MD · University of North Carolina, Chapel Hill

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2020-03-06
Completion
2020-08-15
FDA Drug
Yes

Countries

  • Democratic Republic of the Congo

Study Locations

More Related Trials

Entities

Diseases

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 NCT03567382 on ClinicalTrials.gov