Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Recruiting
Phase 4
Interventional Study
Hepatitis B Virus - Chronic Active
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 150 (estimated)
- Sponsor
- ANRS, Emerging Infectious Diseases · Government
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About This Trial
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 sh…
Trial Locations
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Eligibility Criteria
Inclusion criteria:
* Pregnant women with a term of less than 24 weeks of amenorrhea;
* HBsAg positive ;
* HBeAg positive or HBeAg negative with a high viral load ( \> 200 000 UI/ml) ;
* 16 years old or more on the inclusion day ;
* Signature of free and informed consent (for pregnant women aged 16…
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