NCT02039362

Brief Summary

The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4 pregnancy

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

January 16, 2014

Last Update Submit

April 26, 2017

Conditions

PregnancyHBV

Outcome Measures

Primary Outcomes (1)

  • Rate of chronically infected (positive HBs Ag) children born from mothers with HBV DNA above 100, 000 I.U/mL being given tenofovir during the last trimester of pregnancy.

    At 9 months after birth

Study Arms (1)

tenofovir

OTHER

tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth

Drug: Tenofovir DF

Interventions

Tenofovir DFDRUG

Tenofovir DF will be started at week 28 of pregnancy and stopped or not, according to the physician's decision, at week 12 after birth

tenofovir

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women
  • positive for HBs Ag
  • HBV DNA above 100,000 I.U/mL

You may not qualify if:

  • HIV co-infection
  • HDV co-infection
  • requiring, according to the physician's decision, a treatment for herself and not only to prevent HBV MTC transmission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Lariboisiere

Paris, 75475, France

Location

Related Publications (1)

  • Sellier PO, Maylin S, Bercot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Benifla JL, Simon F, Bergmann JF. Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women. Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793.

    PMID: 27879486DERIVED

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pierre O SELLIER, MD, PhD

    Hopital Lariboisiere, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at Paris VII University (Denis Diderot), physician

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

July 1, 2012

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)