Hepatitis B Virus InfectionPhase 4NCT03695029
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
A Phase 4 study testing Tenofovir Alafenamide in people with Hepatitis B Virus Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hepatitis B Virus Infection
- What is being tested?
- Tenofovir Alafenamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Dec 2010to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20-45 years in 28 to 32 weeks of pregnancy
- Positive HBsAg and HBeAg
- Serum viral load above 6 log10 IU/mL
Who cannot join
- Major systemic disease of the mother or fetus
- Positive anti-HIV or anti-HCV
- Under treatment of antiviral therapy
- Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
- Pregnant woman whose amniocentesis reveals any genetic abnormality
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ivy Chiou, +886-2-23123456 ext. 71737, ivyntuh@gmail.com
About this study
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.
Read the detailed description
This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.
- Conditions
- Hepatitis B Virus Infection
- Being tested
- Tenofovir Alafenamide
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir AlafenamideDrug
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum. Receives: Drug: Tenofovir Alafenamide |
| control group | No intervention | control group receive no drug, only follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child HBsAg 6 mo
Serum status of HBsAg of the infants at 6 months old
Measured: 6 months after delivery
Secondary outcomes (7)
Child HBsAg 12 mo
Serum status of HBsAg of the infants at 12 months old
Measured: 12 months after delivery
Maternal ALT elevation
Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery
Measured: 6 months after delivery
Maternal HBeAg-seroconverion
HBeAg-seroconversion rate within 12 months after delivery
Measured: 12 months after delivery
Maternal renal
Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery
Measured: 6 and 12 months post delivery
Materna bone marker
Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery
Measured: 6 and 12 months post delivery
Children's growth
Children's growth: height (cm) in Z score at 6 and 12 months after birth
Measured: 6 and 12 months after birth
Children's growth
Children's growth: weight (kg) in Z score at 6 and 12 months after birth
Measured: 6 and 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start29 Dec 2010
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695029
- Sponsor's protocol ID
- 201010078M
- Status last verified
- Nov 2020
- First submitted
- 20 Sep 2018
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wen WH, Liu CJ, Lai MW, Tsai MC, Mu SC, Lee CL, Cheng SW, Hsu JJ, Lin YC, Hu JJ, Shu CT, Lin MW, Yang YJ, Hu KC, Chien RN, Ko SC, Chen YC, Shih JC, Lee CN, Chen HL, Chang MH. Peripartum ALT Flares Predict Earlier Postpartum HBeAg Clearance in Highly Viremic HBV-Infected Women: A Long-term Follow-up Study. JHEP Rep. 2026 Jun 25:101936. doi: 10.1016/j.jhepr.2026.101936. Online ahead of print.
PubMed 42349783Chen HL, Lee CN, Chang CH, Lai MW, Tsai MC, Mu SC, Liu CJ, Shih JC, Wen WH, Hu RT, Huang CP, Hu KC, Chen CP, Lee CL, Chien RN, Chang KC, Hsu HY, Lee CC, Ni YH, Chang MH. Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes. Liver Int. 2024 Jun;44(6):1422-1434. doi: 10.1111/liv.15873. Epub 2024 Mar 8.
PubMed 38456620
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT03695029
- Acronym / sponsor ID
- 201010078M
- Conditions
- Hepatitis B Virus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Dec 2010 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.
Detailed description
This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Tenofovir AlafenamidePregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum. |
| control group | No intervention | –control group receive no drug, only follow-up |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 20-45 years in 28 to 32 weeks of pregnancy
- Positive HBsAg and HBeAg
- Serum viral load above 6 log10 IU/mL
Key exclusion criteria (5 listed)
- Major systemic disease of the mother or fetus
- Positive anti-HIV or anti-HCV
- Under treatment of antiviral therapy
- Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
- Pregnant woman whose amniocentesis reveals any genetic abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir AlafenamidePregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum. | Drug | treatment group |
Primary outcome
Child HBsAg 6 mo
Time frame: 6 months after delivery
Serum status of HBsAg of the infants at 6 months old
7 secondary outcomes
Child HBsAg 12 mo
Time frame: 12 months after delivery
Maternal ALT elevation
Time frame: 6 months after delivery
Maternal HBeAg-seroconverion
Time frame: 12 months after delivery
Maternal renal
Time frame: 6 and 12 months post delivery
Materna bone marker
Time frame: 6 and 12 months post delivery
Children's growth
Time frame: 6 and 12 months after birth
Children's growth
Time frame: 6 and 12 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Derived from this study: PubMed 42349783Wen WH, Liu CJ, Lai MW, Tsai MC, Mu SC, Lee CL, Cheng SW, Hsu JJ, Lin YC, Hu JJ, Shu CT, Lin MW, Yang YJ, Hu KC, Chien RN, Ko SC, Chen YC, Shih JC, Lee CN, Chen HL, Chang MH. Peripartum ALT Flares Predict Earlier Postpartum HBeAg Clearance in Highly Viremic HBV-Infected Women: A Long-term Follow-up Study. JHEP Rep. 2026 Jun 25:101936. doi: 10.1016/j.jhepr.2026.101936. Online ahead of print.
- Derived from this study: PubMed 38456620Chen HL, Lee CN, Chang CH, Lai MW, Tsai MC, Mu SC, Liu CJ, Shih JC, Wen WH, Hu RT, Huang CP, Hu KC, Chen CP, Lee CL, Chien RN, Chang KC, Hsu HY, Lee CC, Ni YH, Chang MH. Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes. Liver Int. 2024 Jun;44(6):1422-1434. doi: 10.1111/liv.15873. Epub 2024 Mar 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Alafenamide in people with Hepatitis B Virus Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Hwei Chang (+886-2-23123456 ext. 71701, changmh@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child HBsAg 6 mo (time frame: 6 months after delivery). 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 NCT03695029, which also lists 2 linked publications.
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 27 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.