Hepatitis B VirusNCT04065230
Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus
An observational study of Hepatitis B Virus and Mother to Child Transmission, run by Southeast University, China at 1 site in China.
Trial summary
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hepatitis B Virus, Mother to Child Transmission
- What is being tested?
- Tenofovir Alafenamide Fumarate tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Aug 2019to Aug 2021
- How long will I take part?
- 64 Weeks
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women in the Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) whose HBsAg and HBeAg are positive are enrolled in the study. TAF is used as antiviral therapy during 24-28 week of gestation.The safety and efficacy of TAF are evaluated.
Who may be able to join
- maternal age: 20 to 35 years
- 20-24 week of gestation
- HBsAg-positive more than 6 months and HBeAg-positive
- HBV DNA> 1000,000 IU/ml
- both husband and wife voluntarily sign informed consent
- with good compliance and comply with follow-up programs
Who cannot join
- mother with co-infection of hepatitis C virus,human immunodeficiency virus
- evidence of decompensated liver disease
- combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study
- have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy
- mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission)
- have a history of kidney injury, creatinine clearance <50ml/min, urine protein positive (>300mg/L)
Show all 13Show fewer
- combined with other chronic diseases and need to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
- the infants' biologic father is a chronic HBV infected person
- symptoms of threatened abortion during early pregnancy
- evidence of hepatic cell carcinoma
- alanine aminotransferase (ALT) > 10 x upper limit of normal(ULN ), or total bilirubin (TBIL) > 3 x ULN or glomerular filtration rate (GFR) < 90 mL (min*1.73 m2), or serum Albumin (ALB) < 25 g/L before enrollment
- fetal malformations detected by B-ultrasound
- participants in other research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
Nanjing, Jiangsu, 210003
Guorong Han, 13851623507, hgr518@163.com
About this study
Official title: A Prospective,Multi-center,Cohort Trial: the Efficacy and Safety of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus(HBV)
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.
- Conditions
- Hepatitis B Virus, Mother to Child Transmission
- Being tested
- Tenofovir Alafenamide Fumarate tablets
- 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 Alafenamide Fumarate tabletsDrug
Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.
| Study group | Role | What they receive |
|---|---|---|
| TAF antiviral therapy group | Not described Receives: Drug: Tenofovir Alafenamide Fumarate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTCT rates in the TAF treated mothers
detectable levels of HBV DNA or HBsAg in the peripheral serum samples of infants at age 28 weeks
Measured: 28 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B VirusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
- Target duration
- 64 Weeks
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-rong Han, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065230
- Sponsor's protocol ID
- H201908
- Status last verified
- Aug 2019
- First submitted
- 18 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Han G, Zhou G, Sun T, Luo X, Xu J, Chen C, Xu W, Jiang S, Wang C. Tenofovir alafenamide in blocking mother-to-child transmission of hepatitis B virus: a multi-center, prospective study. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10551-10558. doi: 10.1080/14767058.2022.2134771. Epub 2022 Oct 17.
PubMed 36253882
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Multi-center,Cohort Trial: the Efficacy and Safety of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus(HBV)
- ClinicalTrials.gov ID
- NCT04065230
- Acronym / sponsor ID
- H201908
- Conditions
- Hepatitis B Virus, Mother to Child Transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 22 Aug 2019 (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.
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 64 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAF antiviral therapy group | – | Drug: Tenofovir Alafenamide Fumarate tablets |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women in the Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) whose HBsAg and HBeAg are positive are enrolled in the study. TAF is used as antiviral therapy during 24-28 week of gestation.The safety and efficacy of TAF are evaluated.
Key inclusion criteria (6 listed)
- maternal age: 20 to 35 years
- 20-24 week of gestation
- HBsAg-positive more than 6 months and HBeAg-positive
- HBV DNA> 1000,000 IU/ml
- both husband and wife voluntarily sign informed consent
Key exclusion criteria (13 listed)
- mother with co-infection of hepatitis C virus,human immunodeficiency virus
- evidence of decompensated liver disease
- combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study
- have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy
- mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission)
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 Alafenamide Fumarate tabletsEligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery. | Drug | TAF antiviral therapy group |
Primary outcome
MTCT rates in the TAF treated mothers
Time frame: 28 weeks post-partum
detectable levels of HBV DNA or HBsAg in the peripheral serum samples of infants at age 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 36253882Han G, Zhou G, Sun T, Luo X, Xu J, Chen C, Xu W, Jiang S, Wang C. Tenofovir alafenamide in blocking mother-to-child transmission of hepatitis B virus: a multi-center, prospective study. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10551-10558. doi: 10.1080/14767058.2022.2134771. Epub 2022 Oct 17.
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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?
An observational study of Hepatitis B Virus and Mother to Child Transmission, run by Southeast University, China at 1 site in China.
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 6 inclusion and 13 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 22 Aug 2019. 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 China. 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.
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 Guorong Han (13851623507, hgr518@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTCT rates in the TAF treated mothers (time frame: 28 weeks post-partum). 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 NCT04065230, which also lists 1 linked publication.
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 22 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.