Hepatitis B, ChronicPhase 4NCT05177926
Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)
A Phase 4 study testing antiviral prophylaxis with Tenofovir Alafenamide Fumarate in people with Hepatitis B, Chronic and Mother to Child Transmission, run by Nanfang Hospital, Southern Medical University at 13 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hepatitis B, Chronic, Mother to Child Transmission
- What is being tested?
- antiviral prophylaxis with Tenofovir Alafenamide Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 13 sitesChina
- Study dates
- 4 Apr 2021to 31 Dec 2023
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman aged 20 to 35 years old
- 24-26 week of gestation
- HBsAg positive more than 6 months and HBeAg positive
- HBV DNA> 200,000 IU/ml
- Informed consent is signed voluntarily by both husband and wife
- Good compliance and able to be followed up as planned
Who cannot join
- Mothers co-infected with HCV and HIV
- Evidence of decompensated cirrhosis and liver cancer
- Mothers had other organ lesions which would affect patient compliance and follow-up plan
- Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation
- Mothers received antiviral therapy within 6 months
- Mothers had history of kidney injury, CCr <50ml/min and urine protein test positive (>300mg/L)
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- Mothers had history of other chronic diseases and had to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
- The infants' biological fathers are infected with HBV
- Symptoms of threatened abortion during early pregnancy
- ALT > 1×upper limit of normal (ULN), or TBIL ≥ 1×ULN or glomerular filtration rate (GFR) < 90 ml/min, or Albumin (ALB) < 25 g/L
- Fetal malformations detected by B-ultrasound during pregnancy
- Participating in other studies
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 9 recruiting
- Recruiting
The First Affiliated Hospital of Jilin University
Changchun
Jing Jiang
- Recruiting
The First People's Hospital of Foshan
Foshan
Honglian Bai
- Recruiting
Guangdong Maternal and Child Care Hospital
Guangzhou
Jianhong Xia
- Active, not recruiting
Guangzhou No. 8 People's Hospital
Guangzhou
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Jinlin Hou
- Active, not recruiting
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou
- Active, not recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou
- Recruiting
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou
Jie Jin
- Active, not recruiting
Xixi Hospital of Hangzhou
Hangzhou
- Recruiting
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
Nanjing
Guorong Han
- Recruiting
Shanghai Public Health Clinical Center
Shanghai
Li Yan
- Recruiting
Shenzhen Baoan Maternal and Child Care Hospital
Shenzhen
Wei Wang
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Yingren Zhao
About this study
Official title: A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.
Read the detailed description
This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called "SHIELD" is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD.
- Conditions
- Hepatitis B, Chronic, Mother to Child Transmission
- Being tested
- antiviral prophylaxis with Tenofovir Alafenamide Fumarate
- Keywords
- hepatitis B virus, mother-to-child transmission, antiviral prophylaxis, Tenofovir Alafenamide
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral prophylaxis with Tenofovir Alafenamide FumarateDrug
All participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV
| Study group | Role | What they receive |
|---|---|---|
| antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF) | Other | All participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery. Receives: Drug: antiviral prophylaxis with Tenofovir Alafenamide Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mother-to-child transmission of HBV
the number of HBV-infected infants relative to all participants enrolled or to all participants who complete follow-up
Measured: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months
Secondary outcomes (1)
Rate of birth defect of infants
the number of infants with birth defect relative to all participants enrolled
Measured: from enrollment to the last mother delivery, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start4 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm study, in which all participants will receive study drug.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Tigermed Consulting Co., Ltd
- Responsible party
- Principal investigator, Jinlin Hou, Nanfang Hospital, Southern Medical University
- Investigators
- Jinlin Hou, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177926
- Sponsor's protocol ID
- Shield-TAF
- Status last verified
- Dec 2021
- First submitted
- 31 Dec 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA
- ClinicalTrials.gov ID
- NCT05177926
- Acronym / sponsor ID
- Shield-TAF
- Conditions
- Hepatitis B, Chronic, Mother to Child Transmission
- Keywords
- hepatitis B virus, mother-to-child transmission, antiviral prophylaxis, Tenofovir Alafenamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences, Tigermed Consulting Co., Ltd
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jan 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.
Detailed description
This is a single-arm multicenter, prospective, clinical study, aiming to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. 330 HBV-infected mothers with high level HBV DNA will be enrolled and receive Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of HBV. Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and post vaccination serological test for infants at 7-12 months of age are collected. A mobile health application called "SHIELD" is used in this study to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information are uploaded into SHIELD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm study, in which all participants will receive study drug.
| Arm | Type | Receives |
|---|---|---|
| antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF) | Other | Drug: antiviral prophylaxis with Tenofovir Alafenamide FumarateAll participants will receive oral Tenofovir Alafenamide Fumarate 25mg, daily, at gestational 27-29 week until delivery. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant woman aged 20 to 35 years old
- 24-26 week of gestation
- HBsAg positive more than 6 months and HBeAg positive
- HBV DNA> 200,000 IU/ml
- Informed consent is signed voluntarily by both husband and wife
Key exclusion criteria (12 listed)
- Mothers co-infected with HCV and HIV
- Evidence of decompensated cirrhosis and liver cancer
- Mothers had other organ lesions which would affect patient compliance and follow-up plan
- Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation
- Mothers received antiviral therapy within 6 months
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 prophylaxis with Tenofovir Alafenamide FumarateAll participants will receive antiviral prophylaxis with Tenofovir Alafenamide Fumarate for preventing of Mother-to-child transmission of HBV | Drug | antiviral prophylaxis with Tenofovir Alafenamide Fumarate (TAF) |
Primary outcome
Rate of mother-to-child transmission of HBV
Time frame: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months
the number of HBV-infected infants relative to all participants enrolled or to all participants who complete follow-up
1 secondary outcome
Rate of birth defect of infants
Time frame: from enrollment to the last mother delivery, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Jinlin Hou study chair
Nanfang Hospital, Southern Medical University
13 sites 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 prophylaxis with Tenofovir Alafenamide Fumarate in people with Hepatitis B, Chronic and Mother to Child Transmission, run by Nanfang Hospital, Southern Medical University at 13 sites 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 12 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
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 Jinlin Hou (86-20-61641941, jlhousmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mother-to-child transmission of HBV (time frame: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2022.