Hepatitis B Clinical Trials

Find Hepatitis B Clinical Trials Near You

Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Cameroon
Hôpital Privé de Tokombéré
RECRUITING
Tokonbéré
Contact Information
Primary
Maaga DOURWE, MD
dourwemaaga2@gmail.com
0697073424
Time Frame
Start Date: 2023-08-22
Estimated Completion Date: 2028-02
Participants
Target number of participants: 150
Treatments
Other: pregnant woman - tenofovir
Participants will be started on tenofovir disoproxil fumarate (TDF) 245 mg one tablet per day from week 28 of pregnancy until 6 weeks postpartum.
Related Therapeutic Areas
Sponsors
Leads: ANRS, Emerging Infectious Diseases

This content was sourced from clinicaltrials.gov

Similar Clinical Trials