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AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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
Show all 10Show fewer
  • 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

Other trials in Thailand

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

Other trials in Laos

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.

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.

  1. Infant hepatitis B infection status

    HBsAg positive confirmed by PCR detection of HBV DNA.

    Measured: Six months of age

Secondary outcomes (8)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Preterm live births

    Proportion of neonates born alive before 37 weeks of pregnancy

    Measured: Delivery

  7. Low birth weight

    Proportion of neonates born alive with birth weight of 2,499 g or less, regardless of gestational age

    Measured: Delivery

  8. 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.

  1. First posted17 Nov 2017
  2. Study start2 Aug 2018
  3. Primary completion13 May 2023
  4. Study completion30 Jun 2025 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Thailand, Laos. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant hepatitis B infection status (time frame: Six months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03343431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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