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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hopital Lariboisière
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02039362
First received: January 16, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039362

Contacts
Contact: Pierre O SELLIER, MD, PhD 00 33 149956339 pierre.sellier@lrb.aphp.fr

Locations
France
Hopital Lariboisiere Recruiting
Paris, France, 75475
Contact: Pierre O SELLIER, MD, PhD    00 33 149956339    pierre.sellier@lrb.aphp.fr   
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Pierre O SELLIER, MD, PhD Hopital Lariboisiere, Paris, France
  More Information

No publications provided

Responsible Party: Stephane Mouly, MD PhD, Professor at Paris VII University (Denis Diderot), physician, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02039362     History of Changes
Other Study ID Numbers: Liver002
Study First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 30, 2014