Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

NCT ID: NCT05403047

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2025-10-31

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 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).

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 fumarate once daily from 28 weeks of pregnancy until 6 weeks after delivery. Newborns will receive the hepatitis B vaccine, starting with one dose at birth, followed by three booster doses, in accordance with the expanded programme of vaccination.

The study aims to show that the addition of maternal antiviral treatment to vaccination at birth followed by three booster doses can be favourably considered in the context where vaccination alone is not sufficient to prevent transmission of the hepatitis B virus from mother to child. A total of 150 pregnant women will be included in the Tokombéré district.

Conditions

Hepatitis B Virus - Chronic Active

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Fumarate, Tenofovir Disoproxil

Intervention Type: DRUG

all participants receive the intervention

Interventions

Fumarate, Tenofovir Disoproxil

all participants receive the intervention

Intervention Type: DRUG

Other Intervention Names

TDF

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 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

dourwe maaga

head of the ANRS 12417 project

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pr Yazdan YAZDANPANAH

Role: STUDY_DIRECTOR

ANRS, Emerging Infectious Diseases

Central Contacts

Maaga Dourwe

Role: CONTACT

dourwemaaga2@gmail.com

0697073424

Other Identifiers

ANRS 12417 TOPCHIB

Identifier Type: -

Identifier Source: org_study_id