- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02039362
Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
April 26, 2017 updated by: Célia Lloret-Linares, MD PhD, Hopital Lariboisière
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75475
- Hopital Lariboisiere
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: tenofovir
tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At 9 months after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (ACTUAL)
January 1, 2016
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
January 16, 2014
First Submitted That Met QC Criteria
January 16, 2014
First Posted (ESTIMATE)
January 17, 2014
Study Record Updates
Last Update Posted (ACTUAL)
April 28, 2017
Last Update Submitted That Met QC Criteria
April 26, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis
- Hepatitis B
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- Liver002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Turku University HospitalUniversity of TurkuCompleted
-
Hopital Antoine BeclereUnknown
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
Clinical Trials on Tenofovir DF
-
Gilead SciencesCompletedChronic Hepatitis BFrance, Germany, United States, Spain
-
Gilead SciencesCompletedHIV InfectionsUnited States
-
ANRS, Emerging Infectious DiseasesMSD FranceNot yet recruitingHIV-1-infectionBrazil, Cambodia, Cameroon, Côte D'Ivoire, France, Mozambique
-
Gilead SciencesCompletedHIV InfectionsUnited Kingdom
-
Biotronik SE & Co. KGCompletedVentricular TachyarrhythmiaGermany, Sweden
-
National Cancer Institute (NCI)Completed
-
Gilead SciencesCompletedHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...Kirby Institute; NCHADS - Ministry of Health of CambodiaWithdrawnHIV Infections | HIV SeronegativityCambodia
-
Shanghai Yao Yuan Biotechnology Ltd. (also known...RecruitingHealthy | Safety and TolerabilityUnited States
-
ImaginAb, Inc.CompletedMetastatic Solid Tumors | Positron-Emission TomographyUnited States