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Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
This study has been completed.
Sponsor:
Hopital Lariboisière
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02039362
First received: January 16, 2014
Last updated: April 26, 2017
Last verified: April 2017
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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:
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| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT02039362
Please refer to this study by its ClinicalTrials.gov identifier: 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):
| 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 |
| Study First Received: | January 16, 2014 |
| Last Updated: | April 26, 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 |
ClinicalTrials.gov processed this record on August 18, 2017