Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Recruiting · NCT05403047 · Interventional (participants receive a specific treatment) · Lead sponsor: ANRS, Emerging Infectious Diseases
View the official record on ClinicalTrials.gov →Interventions studied
Fumarate, Tenofovir Disoproxil
What this trial is about
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).
Who can take part
Age range
16 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 to 21, the participant's consent as well as the authorization of a parent/adult husband/ legal tutor will be collected) which also includes consent for the children
Exclusion criteria
- HIV co-infection;
- Women treated for HBV;
- Creatinine clearance \<30 ml / min;
- Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);
- Disease or treatment contraindicating the taking of TDF.
Where it is running
1 location listed.
- Hôpital Privé de Tokombéré - Tokonbéré, Cameroon