Hepatitis B Virus Infection, PregnancyPhase 4NCT01312012
The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test
A Phase 4 study testing antiviral therapy in people with Hepatitis B Virus Infection, Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to < 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. 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, Pregnancy
- What is being tested?
- antiviral therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to 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
- pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral load above 8log10 copies per mL
Who cannot join
- major systemic disease
- Pregnant woman with infection of human immunodeficiency virus or hepatitis C virus
- Pregnant woman is receiving any drug with antiviral activity or any form of drug therapy for hepatitis B virus
- 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, 10002
Mei-Hwei Chang, PhD, 886+02-23123456 ext. 71723, changmh@ntu.edu.tw
Huey-Ling Chen, PhD, 886+02-23123456 ext. 71722, hueyling@ntu.edu.tw
About this study
Official title: The Effectiveness and Feasibility of Using Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test and Follow-up Study
Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to < 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. To further reducing the HBV infection in our people, strategies in reducing infection rate in this high risk group are mandatory. Previous small scale studies using lamivudine treatment in pregnant woman in the third trimester has proved effective in reducing children infection rate. The aims of the present study are to conduct a clinical trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6 months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1, 6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother after treatment.
A follow-up study for investigating safety of mothers and children that has been exposed to maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant hepatitis B virus (HBV) transmissions is conducted. The follow-up study included mother-children pairs 2-4 years after delivery of the children.
- Conditions
- Hepatitis B Virus Infection, Pregnancy
- Being tested
- antiviral therapy
- Keywords
- hepatitis B virus,mother-infant transmission, nucleoside analog,pregnant women
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral therapyDrug
100-120 pregnant women seropositive for both HBeAg and HBsAg and with hepatitis B viral DNA level > 10 8 copies/mL. Among them, 55-65 pregnant women will receive TDF therapy 300 mg once daily, starting from the gestational age 30-32 (the 3rd trimester) until 4 weeks after delivery of the neonate under informed consent. The total treatment duration will be 3-4 months. Another 45-55 pregnant women with the same serum HBAg and HBsAg and HBV DNA status will be enrolled as the control group with no TDF therapy ( An open-labeled study)
| Study group | Role | What they receive |
|---|---|---|
| The effectiveness and feasibility, using antiviral therapy | Experimental | Experimental: Subjects receive tenofovir disoproxil fumarate (TDF) oral use prior to delivery in pregnant women with positive serum HBeAg and HBsAg and high HBV DNA levels > 10^8copies / mL, to reduce the rate of mother to infant transmission of HBV infection, and also to monitor the safety of the therapy. Receives: Drug: antiviral therapy |
| Control | No intervention | Subjects receive no intervention, but with blood tests for mothers and infants before and after delivery, as a comparative group to experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child-HBsAg
serum status of HBsAg of the infants at 6 months old( >180 days).
Measured: 6 months after delivery
Secondary outcomes (8)
Child HBsAg
Serum HBsAg positivity of the infants at 12 months old, to see whether this child indeed becomes a chronic carrier of HBV.
Measured: 12 months after birth
Children growth parameters
body weight and length Z score according to age
Measured: 0-5 years after birth
Children HBV status
HBsAg and anti-HBs positivity rates
Measured: 0-5 years after birth
Children serum biochemistry
Rates of abnormal levels of serum ALT(U/L), creatinine (mg/dL) and calcium (mmol/L)
Measured: 0-5 years after birth
Maternal HBeAg seroconversion rate
Maternal HBeAg seroconversion rate, the time of HBeAg (+) to convert to HBeAg(-) after delivery
Measured: delivery to 5 years after delivery
Maternal ALT elevation
The extent (folds of upper limit of normal, ULN) of ALT elevation and duration.
Measured: delivery to 5 years after delivery
Maternal HBV DNA
Change of levels of HBV DNA (log IU/mL) from baseline
Measured: delivery to 5 years after delivery
Children bone growth
comparisons of BAP levels(U/L) and bone density (DEXA) between control and treatment group
Measured: 2-5 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B Virus Infection, PregnancyStudies 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
- Treatment
- 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
- Investigators
- Mei-Hwei Chang, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312012
- Sponsor's protocol ID
- 201010078M, 201507025RINC
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2011
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 42349783Hsu HY, Chen HL, Chiang CL, Lai MW, Mu SC, Wen WH, Cheng SW, Hu JJ, Chang KC, Lee CN, Liu CJ, Wu JF, Ni YH, Chang MH; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study). Characterization of Hepatitis B Virus in Tenofovir-Treated and Untreated Chronically Infected Mothers and Their Immunoprophylaxis Failure Infants. Clin Infect Dis. 2023 Feb 8;76(3):e783-e790. doi: 10.1093/cid/ciac539.
PubMed 35789261Wen WH, Chen HL, Shih TT, Wu JF, Ni YH, Lee CN, Zhao LL, Lai MW, Mu SC, Tung YC, Hsu HY, Chang MH; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study)(double dagger). Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate. J Hepatol. 2020 Jun;72(6):1082-1087. doi: 10.1016/j.jhep.2020.01.021. Epub 2020 Feb 8.
PubMed 32044401Chang KC, Chang MH, Lee CN, Chang CH, Wu JF, Ni YH, Wen WH, Shyu MK, Lai MW, Chen SM, Hu JJ, Lin HH, Hsu JJ, Mu SC, Lin YC, Liu CJ, Chen DS, Lin LH, Chen HL; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study). Decreased neonatal hepatitis B virus (HBV) viremia by maternal tenofovir treatment predicts reduced chronic HBV infection in children born to highly viremic mothers. Aliment Pharmacol Ther. 2019 Aug;50(3):306-316. doi: 10.1111/apt.15321. Epub 2019 Jul 4.
PubMed 31271463
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
- The Effectiveness and Feasibility of Using Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test and Follow-up Study
- ClinicalTrials.gov ID
- NCT01312012
- Acronym / sponsor ID
- 201010078M, 201507025RINC
- Conditions
- Hepatitis B Virus Infection, Pregnancy
- Keywords
- hepatitis B virus,mother-infant transmission, nucleoside analog,pregnant women
- 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
- Jan 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Mar 2011 (estimated)
- 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.
Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to < 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. To further reducing the HBV infection in our people, strategies in reducing infection rate in this high risk group are mandatory. Previous small scale studies using lamivudine treatment in pregnant woman in the third trimester has proved effective in reducing children infection rate. The aims of the present study are to conduct a clinical trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6 months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1, 6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother after treatment.
A follow-up study for investigating safety of mothers and children that has been exposed to maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant hepatitis B virus (HBV) transmissions is conducted. The follow-up study included mother-children pairs 2-4 years after delivery of the children.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effectiveness and feasibility, using antiviral therapy | Experimental | Drug: antiviral therapyExperimental: Subjects receive tenofovir disoproxil fumarate (TDF) oral use prior to delivery in pregnant women with positive serum HBeAg and HBsAg and high HBV DNA levels > 10^8copies / mL, to reduce the rate of mother to infant transmission of HBV infection, and also to monitor the safety of the therapy. |
| Control | No intervention | –Subjects receive no intervention, but with blood tests for mothers and infants before and after delivery, as a comparative group to experimental arm. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral load above 8log10 copies per mL
Key exclusion criteria (5 listed)
- major systemic disease
- Pregnant woman with infection of human immunodeficiency virus or hepatitis C virus
- Pregnant woman is receiving any drug with antiviral activity or any form of drug therapy for hepatitis B virus
- 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 |
|---|---|---|
| antiviral therapy100-120 pregnant women seropositive for both HBeAg and HBsAg and with hepatitis B viral DNA level > 10 8 copies/mL. Among them, 55-65 pregnant women will receive TDF therapy 300 mg once daily, starting from the gestational age 30-32 (the 3rd trimester) until 4 weeks after delivery of the neonate under informed consent. The total treatment duration will be 3-4 months. Another 45-55 pregnant women with the same serum HBAg and HBsAg and HBV DNA status will be enrolled as the control group with no TDF therapy ( An open-labeled study) | Drug | The effectiveness and feasibility, using antiviral therapy |
Primary outcome
Child-HBsAg
Time frame: 6 months after delivery
serum status of HBsAg of the infants at 6 months old( >180 days).
8 secondary outcomes
Child HBsAg
Time frame: 12 months after birth
Children growth parameters
Time frame: 0-5 years after birth
Children HBV status
Time frame: 0-5 years after birth
Children serum biochemistry
Time frame: 0-5 years after birth
Maternal HBeAg seroconversion rate
Time frame: delivery to 5 years after delivery
Maternal ALT elevation
Time frame: delivery to 5 years after delivery
Maternal HBV DNA
Time frame: delivery to 5 years after delivery
Children bone growth
Time frame: 2-5 years 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 35789261Hsu HY, Chen HL, Chiang CL, Lai MW, Mu SC, Wen WH, Cheng SW, Hu JJ, Chang KC, Lee CN, Liu CJ, Wu JF, Ni YH, Chang MH; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study). Characterization of Hepatitis B Virus in Tenofovir-Treated and Untreated Chronically Infected Mothers and Their Immunoprophylaxis Failure Infants. Clin Infect Dis. 2023 Feb 8;76(3):e783-e790. doi: 10.1093/cid/ciac539.
- Derived from this study: PubMed 32044401Wen WH, Chen HL, Shih TT, Wu JF, Ni YH, Lee CN, Zhao LL, Lai MW, Mu SC, Tung YC, Hsu HY, Chang MH; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study)(double dagger). Long-term growth and bone development in children of HBV-infected mothers with and without fetal exposure to tenofovir disoproxil fumarate. J Hepatol. 2020 Jun;72(6):1082-1087. doi: 10.1016/j.jhep.2020.01.021. Epub 2020 Feb 8.
- Derived from this study: PubMed 31271463Chang KC, Chang MH, Lee CN, Chang CH, Wu JF, Ni YH, Wen WH, Shyu MK, Lai MW, Chen SM, Hu JJ, Lin HH, Hsu JJ, Mu SC, Lin YC, Liu CJ, Chen DS, Lin LH, Chen HL; Taiwan Study Group for the Prevention of Mother-to-Infant Transmission of HBV (PreMIT study). Decreased neonatal hepatitis B virus (HBV) viremia by maternal tenofovir treatment predicts reduced chronic HBV infection in children born to highly viremic mothers. Aliment Pharmacol Ther. 2019 Aug;50(3):306-316. doi: 10.1111/apt.15321. Epub 2019 Jul 4.
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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.
Mei-Hwei Chang, PhD principal investigator
National Taiwan University
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 antiviral therapy in people with Hepatitis B Virus Infection, Pregnancy, 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 1 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, PhD (886-02-23123456 ext. 71723, 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 (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 NCT01312012, which also lists 4 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.