Back to resultsPrevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
Primary Purpose
Pregnancy, HBV
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tenofovir DF
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy
Eligibility 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
Sites / Locations
- Hopital Lariboisiere
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
tenofovir
Arm Description
tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02039362
Brief Title
Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital Lariboisière
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, HBV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tenofovir
Arm Type
Other
Arm Description
tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth
Intervention Type
Drug
Intervention Name(s)
Tenofovir DF
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre O SELLIER, MD, PhD
Organizational Affiliation
Hopital Lariboisiere, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75475
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27879486
Citation
Sellier PO, Maylin S, Bercot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Benifla JL, Simon F, Bergmann JF. Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women. Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793.
Results Reference
derived
Learn more about this trial
Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy
We'll reach out to this number within 24 hrs