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Stop Hep B @ Birth

NCT04998838 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-08-10

No results posted yet for this study

Summary

Single arm, prospective open-label study of a care model consisting of two components: Component I aims to achieve high coverage of interventions to prevent maternal-to-child transmission of hepatitis B virus: antenatal tenofovir, and timely newborn administration of hepatitis B birth dose vaccine and hepatitis B immune globulin; Component II aims to achieve high coverage of screening, vaccination, and anti-viral therapy for HBV among household members of women with chronic HBV infection.

Conditions

Interventions

DRUG

Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG)

Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV

DRUG

Regular Myanmar treatment

Treated according to normal Myanmar processes for HBV positive patients

Sponsors & Collaborators

  • Myanmar Liver Foundation

    lead OTHER

Principal Investigators

  • Khin Phone Kyi, MD · Myanmar Liver Foundation

  • Adam K Richards, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-12-30
Completion
2023-06-30

Countries

  • Burma

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 NCT04998838 on ClinicalTrials.gov