Trials Sponsors Conditions Drugs Pricing

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
+2 more secondary outcomes

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 DisoproxilDrug

all participants receive the intervention

Also known as: TDF

pregnant woman - tenofovir

Eligibility Criteria

Age16 Years+

Sexfemale(Gender-based eligibility)

Gender Eligibility Detailspregnant woman

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Pregnant women with a term of less than 24 weeks of amenorrhea;

Sponsors & Collaborators

ANRS, Emerging Infectious Diseases
Governmentlead

Study Sites (1)

Hôpital Privé de Tokombéré

Tokonbéré, Cameroon

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Jean-Pierre ADOUKARA, MD
Hôpital de Tokombéré
PRINCIPAL INVESTIGATOR

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

Actual (reported)

Primary Completion

August 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

pregnant woman - tenofovir

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

pregnant woman - tenofovir

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations