Status:
UNKNOWN
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
Hepatitis B Virus - Chronic Active
Eligibility:
FEMALE
16+ years
Phase:
PHASE4
Brief Summary
IIn this study, pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate from the 28th week of amenorrhoea until 6 weeks after delivery. Their...
Detailed Description
This is a prospective, single-arm, open-label, descriptive, phase IV clinical trial in HBsAg and HBeAg positive pregnant women. Eligible pregnant women will receive 245 mg of tenofovir disoproxil fuma...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05403047
Start Date
July 1 2022
End Date
October 1 2025
Last Update
June 3 2022
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