Phase 4 Hepatitis B Trial, Recruiting NCT05403047 Sponsor: ANRS, Emerging Infectious Diseases Condition: Hepatitis B
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Phase 4 Hepatitis B Trial, Recruiting

NCT05403047
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Pregnant women who are less than 24 weeks into their pregnancy
  • People who test positive for HBsAg (a marker showing hepatitis B is present in the blood)
  • People who test positive for HBeAg (another hepatitis B marker), or who test negative for HBeAg but have a high level of the hepatitis B virus in their blood
  • People who are 16 years of age or older at the time of joining the trial
  • People who are willing and able to sign a consent form agreeing to take part (for those aged 16 to 21, both the participant's own agreement and the approval of a parent, adult husband, or legal guardian will be needed, and consent also covers the child born during the trial)

Who may not be able to join:

  • People who also have an HIV infection
  • People who are already receiving treatment for hepatitis B
  • People whose kidneys are not working well enough (specifically, a kidney filtration rate below 30 ml/min) (confirm with trial site)
  • People where there are concerns that the child's hepatitis B vaccination schedule — including the birth dose and follow-up booster shots — may not be properly followed
  • People who have a health condition, or who are taking a medication, that would make it unsafe to take the drug TDF (tenofovir disoproxil fumarate)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Jean-Pierre ADOUKARA, MD, Hôpital de Tokombéré

Phone: 0697073424

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
ANRS, Emerging Infectious Diseases
Registry
ClinicalTrials.gov
Start date
22 August 2023
Est. completion
1 August 2027

Where this trial is recruiting

Cameroon

Primary endpoints

Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population,

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov