Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT02039362

First Posted: January 17, 2014

Last Update Posted: April 28, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Célia Lloret-Linares, MD PhD, Hopital Lariboisière

Purpose

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.

Condition	Intervention	Phase
Pregnancy HBV	Drug: Tenofovir DF	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Tenofovir Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Célia Lloret-Linares, MD PhD, Hopital Lariboisière:

Primary Outcome Measures:

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. [ Time Frame: At 9 months after birth ]


Enrollment:	37
Study Start Date:	July 2012
Study Completion Date:	July 2016
Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
tenofovir tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth	Drug: Tenofovir DF 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

Detailed Description:

The prevalence of HBs Ag carriage in pregnant women varies in France, according to the native country, with higher rates in those originating from sub-Saharan Africa and Asia (5 to 8% in Parisian area). The level of HBV DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). The rate of vertical transmission (Yuan J et al. J Viral Hepatitis 2006) was 0% in newborns to mothers with HBV DNA less than 100,000 copies/mL and up to more than 40% in newborns to mothers with HBV DNA above 8 Log10 copies/mL, despite serovaccination at birth, thus justifying the use of tenofovir DF during the last trimester of pregnancy in highly viraemic pregnant women, as mentionned in EASL 2012 Guidelines. Data are needed concerning the results of this strategy in western countries, justifying this prospective study.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039362

Locations


France
Hopital Lariboisiere
Paris, France, 75475

Sponsors and Collaborators

Hopital Lariboisière

Investigators


Principal Investigator:	Pierre O SELLIER, MD, PhD	Hopital Lariboisiere, Paris, France

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sellier PO, Maylin S, Berçot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Bénifla 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.


Responsible Party:	Célia Lloret-Linares, MD PhD, Professor at Paris VII University (Denis Diderot), physician, Hopital Lariboisière
ClinicalTrials.gov Identifier:	NCT02039362 History of Changes
Other Study ID Numbers:	Liver002
First Submitted:	January 16, 2014
First Posted:	January 17, 2014
Last Update Posted:	April 28, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Hepatitis B Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Hepatitis Liver Diseases Digestive System Diseases Tenofovir	Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents

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