Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
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ClinicalTrials.gov Identifier: NCT02039362 |
Recruitment Status
:
Completed
First Posted
: January 17, 2014
Last Update Posted
: April 28, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy HBV | Drug: Tenofovir DF | Phase 4 |
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 |
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
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- 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 ]

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

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
France | |
Hopital Lariboisiere | |
Paris, France, 75475 |
Principal Investigator: | Pierre O SELLIER, MD, PhD | Hopital Lariboisiere, Paris, France |
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 |
First Posted: | January 17, 2014 Key Record Dates |
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 |