Hepatitis BPhase 3NCT03343431
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
A Phase 3 study testing Anti-HBV antiviral prophylaxis in people with Hepatitis B and Pregnancy, run by Institut de Recherche pour le Developpement at 20 sites in 2 countries.
Trial summary
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hepatitis B, Pregnancy
- What is being tested?
- Anti-HBV antiviral prophylaxis
- Type of treatment
- Pill or oral medicine
- How many people
- 504 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 2 Aug 2018to 30 Jun 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy
- Age ≥18 years
- Negative HIV antibody test during current pregnancy
- Positive HBsAg test during current pregnancy
- Positive HBeAg using a rapid test during current pregnancy
- Absence of clinical symptoms of liver disease
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- Gestational age of 28 weeks (+/- 7 days) based on the obstetrician judgment guided by the review of the date of last menstruation period.
- Willing and able to provide written informed consent
- Agreeing to bring her infants(s) at the planned study visits at one of the study site until the last visit (18 months after birth) and to inform the site investigators if plans to move to another place and not be able to return to the clinic
- Understand the need for adequate infant immunization for her infant(s) and accept that blood draws will be performed to determine the infant HBV infection status
Who cannot join
- Receipt of anti-HBV antivirals at any time during the last 9 months
- Known liver cirrhosis or evidence of hepatocellular carcinoma
- Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula
- Confirmed dipstick proteinuria >1+ (>30 mg/dL) or normoglycemic glycosuria
- Evidence of pre-existing fetal anomalies incompatible with life
- Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or compromise adherence to treatment and satisfactory follow up in the study.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Thailand12 sites
Nopparat Rajathanee Hospital
Bangkok, 10230
Prapokklao Hospital
Chanthaburi, 22000
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, 56110
Health Promotion Center Region 1
Chiang Mai, 50100
Nakornping Hospital
Chiang Mai, 50180
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000
Chonburi Hospital
Chon Buri, 20000
Banglamung Hospital
Chon Buri, 20150
Lampang Hospital
Lampang, 52000
Lamphun Hospital
Lamphun, 51000
Samutprakarn Hospital
Mueang Samut Prakan, 10280
Samutsakhon Hospital
Samut Sakhon, 74000
Laos8 sites
Champasak Hospital
Champasak
Luang Prabang Provincial Hospital
Luang Prabang
Sayaboury Hospital
Sainyabuli
Savannakhet Provincial hospital
Savannakhet
103 Hospital
Vientiane
Mahosot Hospital
Vientiane
Mother and Newborn Hospital
Vientiane
Setthathirath Hospital
Vientiane
About this study
Official title: A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
Read the detailed description
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.
- Conditions
- Hepatitis B, Pregnancy
- Being tested
- Anti-HBV antiviral prophylaxis
- Keywords
- Hepatitis B, Hepatitis B eAg, Pregnancy
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HBV antiviral prophylaxisDrug
Also called tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant hepatitis B infection status
HBsAg positive confirmed by PCR detection of HBV DNA.
Measured: Six months of age
Secondary outcomes (8)
Maternal HBV DNA changes
Description of the effect of tenofovir disoproxil fumarate on maternal HBV DNA levels
Measured: From enrollment until end of study treatment scheduled 2 months after delivery
Infant levels of anti-HBs antibodies
Levels of anti-HBs antibodies in infants in the absence of HBIg administration at birth
Measured: At 1, 2, 4, 6, and 12 months of age
HBV infection status in all infants regardless of maternal response to study treatment
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
Measured: At 6 months of age
Serious adverse events
Occurrence of maternal serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment
Measured: From enrollment until 12 months postpartum
Serious adverse events
Occurrence of infant serious adverse events (ICH SAEs) including DAIDS grade 4 signs and symptoms regardless of their relatedness to the study treatment
Measured: From birth until 12 months of age
Preterm live births
Proportion of neonates born alive before 37 weeks of pregnancy
Measured: Delivery
Low birth weight
Proportion of neonates born alive with birth weight of 2,499 g or less, regardless of gestational age
Measured: Delivery
Active or previous transient infection in children
Detection of anti-HBc antibodies among all infants
Measured: At 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start2 Aug 2018
- Primary completion13 May 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the intervention
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Chiang Mai University, Ministry of Health, Thailand, Ministry of Health, Lao PDR
- Responsible party
- Principal investigator, GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement
- Investigators
- Gonzague Jourdain, MD, PhD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343431
- Sponsor's protocol ID
- iTAP-2
- Status last verified
- May 2025
- First submitted
- 6 Nov 2017
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are willing to share our data to answer important research questions requiring large datasets, after completion of the original research plan and substudies. Data-sharing agreements will include: an approval of the research plan by appropriate ethics committees, a commitment to using data for research purposes only and to securing the data or/and the samples using appropriate methods. Data used for publications will be released in a timely manner. De-identified study data will be accessible through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub or DASH (dash.nichd.nih.gov/). However, as of May 25, 2025, the DASH website will be unable to support new submissions for the next several months. The PI will submit the data when new submissions are open.