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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; HBV	Drug: Tenofovir DF	Phase 4

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
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
Study Start Date :	July 2012
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	July 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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. [ Time Frame: At 9 months after birth ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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