Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
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|ClinicalTrials.gov Identifier: NCT03343431|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B Pregnancy||Drug: Anti-HBV antiviral prophylaxis||Phase 3|
This is a prospective multi-center, multi-country (Thailand and Lao PDR), open-label, single arm clinical trial in HBsAg and HBeAg positive pregnant women (from 28 weeks until one year postpartum) and their infants (until 18 months of age). Pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate 300 mg once daily from 28 weeks of pregnancy until two months postpartum. Their infants will receive hepatitis B (HB) immunization, starting with the first dose soon after birth.
The study aims to show that substituting maternal antiviral treatment for infant HBIg can be favorably considered in settings where HBIg plus vaccine has been used as well as in settings where only vaccine is used. A significant improvement over the standard HBIg + vaccine strategy would be that adding an antiviral strategy results in less than 2% transmission. A total of 499 women and their infants will be enrolled in public hospitals in Thailand and Lao PDR.
The study will be monitored by a Data and Safety Monitoring Board (DSMB) at least annually.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||499 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants receive the intervention|
|Masking:||None (Open Label)|
|Official Title:||A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus|
|Actual Study Start Date :||August 2, 2018|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2023|
- Drug: Anti-HBV antiviral prophylaxis
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartumOther Name: tenofovir disoproxil fumarate
- Infant hepatitis B infection status [ Time Frame: Six months of age ]HBsAg positive confirmed by PCR detection of HBV DNA.
- Maternal HBV DNA changes [ Time Frame: From enrollment until end of study treatment scheduled 2 months after delivery ]Description of the effect of tenofovir disoproxil fumarate on maternal HBV DNA levels
- Infant levels of anti-HBs antibodies [ Time Frame: At 1, 2, 4, 6, and 12 months of age ]Levels of anti-HBs antibodies in infants in the absence of HBIg administration at birth
- HBV infection status in all infants regardless of maternal response to study treatment [ Time Frame: At 6 months of age ]HBsAg positive confirmed by PCR detection of HBV DNA in all infants, i.e. including those born to women with unsatisfactory virological response to study treatment
- Serious adverse events [ Time Frame: From enrollment until 12 months postpartum ]Occurrence of maternal serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment
- Serious adverse events [ Time Frame: From birth until 12 months of age ]Occurrence of infant serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment
- Preterm live births [ Time Frame: Delivery ]Proportion of neonates born alive before 37 weeks of pregnancy
- Low birth weight [ Time Frame: Delivery ]Proportion of neonates born alive with birth weight of 2,499 g or less, regardless of gestational age
- Active or previous transient infection in children [ Time Frame: At 18 months of age ]Detection of anti-HBc antibodies among all infants
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): NCT03343431
|Contact: Gonzague Jourdain, MD, PhD||+66818830065||Gonzague.Jourdain@ird.fr|
|Contact: Nicole Ngo-Giang-Huong, PharmD, PhD||+66898511178||Nicole.Ngo-Giang-Huong@phpt.org|
|Principal Investigator:||Gonzague Jourdain, MD, PhD||Institut de Recherche pour l e Développement|