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Reducing Vertical Transmission of Hepatitis B in Africa

Study acronym: REVERT-B
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 26% 450 → 334 participants
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Enrollment reduced: 450 → 334 participants Secondary endpoints: 11 to 15 · Eligibility criteria expanded, about 1 wordv14 Show 2 more changesShow less
    • Secondary endpoints: 11 to 15
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion date changed from estimate of Aug 1, 2026 to May 1, 2026v12
  4. Primary completion date: Dec 31, 2025 to Aug 1, 2026 Trial status: Recruiting to Active, Not Recruiting · Site details revisedv11 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  5. Completion date: Dec 31, 2025 to Dec 31, 2026v10
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Primary completion date: Dec 1, 2024 to Dec 31, 2025 Completion date: Mar 31, 2025 to Dec 31, 2025v8 Show 1 more changeShow less
    • Completion date: Mar 31, 2025 to Dec 31, 2025
  3. Eligibility criteria revisedv7 See this version in full on ClinicalTrials.gov ↗
  4. Eligibility criteria expanded, about 5 wordsv6 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Dec 31, 2023 to Dec 1, 2024 Completion date: Jun 1, 2024 to Mar 31, 2025v5 Show 1 more changeShow less
    • Completion date: Jun 1, 2024 to Mar 31, 2025
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 15, 2021 to Sep 3, 2021 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Jul 15, 2021 to Sep 3, 2021
    • Site details revised
  7. Start date: Mar 1, 2021 to Jul 15, 2021v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.
Trial Details
NCT Number NCT04704024
Lead Sponsor University of Alabama at Birmingham
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Hepatitis B Infection
Enrollment 334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov