Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2015 by Hopital Lariboisière
Sponsor:
Hopital Lariboisière
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02039362
First received: January 16, 2014
Last updated: September 30, 2015
Last verified: September 2015
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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: | 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: | July 2016 |
| Estimated Primary Completion Date: | July 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) |
| 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
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
| 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: | September 30, 2015 |
| 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 |
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 September 29, 2016