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

NCT05403047 | Recruiting Phase 4 DMC

• 1 other identifier: ANRS 12417 TOPCHIB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatitis B Virus - Chronic Active

Outcome Measures

Primary Outcomes (1)

• Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population,

  Proportion of HBsAg-positive children between 9 and 12 months of age in the study population, assessed by an automated test (mini VIDAS)

  measured between 36 and 48 weeks of life of the child of the mothers included in the study

Secondary Outcomes (7)

• Proportion of eligible women who accepted the intervention among eligible women offered the intervention (acceptance rate)

  measured from 7 months of pregnancy to 8 weeks postpartum

• Compliance with treatment

  from 28 weeks of pregnancy to 8 weeks postpartum

• Progression of viral load

  measured from 24 weeks of pregnancy until the end of treatment

• Estimate the protection rate of children with anti-HBs antibody level > 10 mIU/mL

  measured between 36 and 48 weeks of life of the child of the mothers included in the study

• Assess the clinical and biological tolerance of TDF administration in mothers and children

  measured from 28 weeks of pregnancy until the end of treatment

Study Arms (1)

pregnant woman - tenofovir

OTHER

Participants will be started on tenofovir disoproxil fumarate (TDF) 245 mg one tablet per day from week 28 of pregnancy until 6 weeks postpartum.

Drug: Fumarate, Tenofovir Disoproxil

Interventions

Fumarate, Tenofovir Disoproxil DRUG

all participants receive the intervention

Also known as: TDF

pregnant woman - tenofovir

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: pregnant woman
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) ;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Hôpital Privé de Tokombéré

Tokonbéré, Cameroon

RECRUITING

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-Pierre ADOUKARA, MD

  Hôpital de Tokombéré

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maaga DOURWE, MD

CONTACT

0697073424; dourwemaaga2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 3, 2022
• Study Start: August 22, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

CA (1)