A Phase 3 interventional study of Anti-HBV antiviral prophylaxis in Hepatitis B and Pregnancy, sponsored by Institut de Recherche pour le Developpement. Active, not recruiting at 20 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Institut de Recherche pour le Developpement · Phase 3, Interventional, and Prevention
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Among 41 studies testing tenofovir in Hepatitis B — none open to participants now, 4 under way, 2 of them phase 3. Tenofovir · Hepatitis B.
Among the 41 studies testing tenofovir in Hepatitis B, this one is the 4th largest by enrollment, is one of 5 that started in 2018, is one of 10 in phase 3, and was the 31st registered.
1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
Browse Hepatitis B studies →None of the 41 studies testing tenofovir in Hepatitis B is open now. The open studies under Hepatitis B, anywhere →
Tenofovir: first FDA approval 2001 (VIREAD), first EMA approval 2002. What it is approved for, and how studies give it, is on its page →
Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 8 · Phase 3 11 · Phase 4 14
First in 2004; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 504 is above the median of 145 across 756 interventional studies indexed under Hepatitis B.
Median enrollment 100 across the 41 interventional studies. Of the 28 that completed or were terminated, 10 (36%) have results posted.
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13 of 41 have an industry lead sponsor. The 10 most frequent:
Institut de Recherche pour le Developpement is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Institut de Recherche pour le Developpement has 4 studies filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
1 of the studies testing tenofovir in Hepatitis B that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05403047ANRS, Emerging Infectious DiseasesEfficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women | 2027-08 |
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Among the 41 studies testing tenofovir in Hepatitis B, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum
Also known as: tenofovir disoproxil fumarate
Infant hepatitis B infection status
HBsAg positive confirmed by PCR detection of HBV DNA.
Time frame: Six months of age
Maternal HBV DNA changes
Description of the effect of tenofovir disoproxil fumarate on maternal HBV DNA levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From birth until 12 months of age
Preterm live births
Proportion of neonates born alive before 37 weeks of pregnancy
Time frame: Delivery
Low birth weight
Proportion of neonates born alive with birth weight of 2,499 g or less, regardless of gestational age
Time frame: Delivery
Active or previous transient infection in children
Detection of anti-HBc antibodies among all infants
Time frame: At 18 months of age
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: At the same time as related publications
Access criteria: See Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub or DASH
Data sharing details ↗ · dash.nichd.nih.gov
Ran from Aug 2018 to primary completion in May 2023, 57 months.
Of 50 phase 3 interventional studies under Hepatitis B, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 57 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir
Institut de Recherche pour le Developpement