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Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

Study acronym: TOPCHIB
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jul 2025 to Aug 2027
    • Start date changed from estimate of Jul 2022 to Aug 22, 2023
    • Study sites: 0 to 1
    • Study completion date: Oct 2025 to Feb 2028
    • Secondary endpoints expanded, about 77 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation. The investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).
Trial Details
NCT Number NCT05403047
Lead Sponsor ANRS, Emerging Infectious Diseases
Conditions
(from sponsor)		 Hepatitis B Virus - Chronic Active
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov